FDA 510(k) Applications for Medical Device Product Code "OLO"
(Orthopedic Stereotaxic Instrument)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K220522 | 7D Surgical | 7D Surgical System - Percutaneous Application (7D Flash Frame) | 05/20/2022 |
| K210457 | 7D Surgical Inc. | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key | 06/21/2021 |
| K201966 | 7D Surgical Inc. | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array | 09/03/2020 |
| K180352 | 7D Surgical Inc. | 7D Surgical System | 05/02/2018 |
| K192140 | 7D Surgical Inc. | 7D Surgical System | 11/05/2019 |
| K210555 | 7D Surgical Inc. | 7D Surgical System - Drill Guide | 03/23/2021 |
| K162375 | 7D SURGICAL INC. | Envision 3D: Image Guidance System | 12/29/2016 |
| K090375 | AESCULAP IMPLANT SYSTEM, INC. | ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 | 06/23/2009 |
| K130887 | AESCULAP IMPLANT SYSTEM, INC. | S4C NAVIGATION INSTRUMENTS | 08/13/2013 |
| K141694 | AESCULAP IMPLANT SYSTEMS, LLC | AESCULAP ORTHOPILOT NEXT GENERATION | 02/24/2015 |
| K153396 | AESCULAP IMPLANT SYSTEMS, LLC | Aesculap OrthoPilot Next Generation | 05/16/2016 |
| K153700 | AESCULAP IMPLANT SYSTEMS, LLC | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments | 07/08/2016 |
| K153603 | ALPHATEC SPINE, INC. | Alphatec Navigation Instruments | 04/29/2016 |
| K223765 | Alphatec Spine, Inc. | ATEC Lateral Navigation Instruments | 03/23/2023 |
| K232413 | Alphatec Spine, Inc. | Fusion Robotic Navigation System | 09/08/2023 |
| K232044 | Alphatec Spine, Inc. | Invictus Robotic Navigation Instruments | 10/06/2023 |
| K182982 | Astura Medical | BridalVeil Navigated Instruments | 01/04/2019 |
| K172166 | Astura Medical | OLYMPIC Navigated Instruments | 04/27/2018 |
| K211188 | Augmedics Ltd | xvision Spine system (XVS) | 07/19/2021 |
| K220905 | Augmedics Ltd. | xvision Spine System | 11/17/2022 |
| K190929 | Augmedics Ltd. | xvision Spine system (XVS) | 12/20/2019 |
| K152574 | BLUE BELT TECHNOLOGIES, INC | Navio | 10/20/2015 |
| K140596 | BLUE BELT TECHNOLOGIES, INC. | NAVIO | 07/02/2014 |
| K143668 | BLUE BELT TECHNOLOGIES, INC. | Navio | 03/20/2015 |
| K170360 | Blue Belt Technologies, Inc. | NAVIO | 05/02/2017 |
| K160537 | Blue Belt Technologies, Inc. | Navio | 05/19/2016 |
| K191223 | Blue Belt Technologies, Inc. | NAVIO | 06/28/2019 |
| K180271 | Blue Belt Technologies, Inc. | NAVIOÖ Surgical System (NAVIO system) | 04/06/2018 |
| K121936 | BLUE BELT TECHNOLOGIES, INC. | NAVIOPFS | 11/30/2012 |
| K193120 | Blue Belt Technologies, Inc. | Real Intelligence Cori | 02/14/2020 |
| K220255 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | 03/29/2022 |
| K220958 | Blue Belt Technologies, Inc. | Real Intelligence Cori | 07/27/2022 |
| K221224 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | 08/19/2022 |
| K201022 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI (CORI) | 06/12/2020 |
| K212537 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI (CORI) | 11/03/2021 |
| K231963 | Blue Belt Technologies, Inc. | REAL INTELLIGENCEÖ CORIÖ | 08/01/2023 |
| K100742 | BLUE ORTHO | EXACTECH GPS | 10/21/2010 |
| K193618 | Blue Ortho | ExactechGPS System | 09/02/2020 |
| K173372 | Blue Ortho | ExactechGPS Total Shoulder Application | 11/24/2017 |
| K213546 | Blue Ortho | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | 01/06/2022 |
| K162567 | Blue Ortho | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | 04/05/2017 |
| K213877 | Blue Ortho | ExactechGPS« System | 05/02/2022 |
| K203679 | Brainlab AG | Automatic Registration | 03/18/2021 |
| K083483 | BRAINLAB AG | BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED | 04/08/2009 |
| K102990 | BRAINLAB AG | BRAINLAB KNEE | 04/04/2011 |
| K093118 | BRAINLAB AG | BRAINLAB KNEE ARTHROSCOPY | 06/11/2010 |
| K110204 | BRAINLAB AG | BRAINLAB TRAUMA | 08/05/2011 |
| K222966 | Brainlab AG | Cirq Arm System (2.0);Alignment System Spine | 10/27/2022 |
| K202320 | Brainlab AG | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System | 12/23/2020 |
| K102251 | BRAINLAB AG | DASH KNEE | 05/17/2011 |
| K193307 | Brainlab AG | HIP7 | 06/02/2020 |
| K220652 | Brainlab AG | Knee 3 | 06/03/2022 |
| K122011 | BRAINLAB AG | NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP | 11/15/2012 |
| K083310 | BRAINLAB AG | SPINE & TRAUMA ICT | 04/01/2009 |
| K183605 | Brainlab AG | Spine & Trauma Navigation | 08/29/2019 |
| K191285 | Brainlab AG | Spine & Trauma Navigation | 06/11/2019 |
| K221618 | Brainlab AG | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System | 08/30/2022 |
| K212245 | Brainlab AG | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning S | 04/13/2022 |
| K223553 | Brainlab AG | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | 08/02/2023 |
| K110021 | BRAINLAB, AG | DASH HIP | 10/18/2011 |
| K220038 | Camber Spine Technologies | Camber Spine Navigation System | 04/29/2022 |
| K201251 | CarboFix Orthopedics Ltd. | CarboClear Navigated Instruments | 08/05/2020 |
| K182721 | Choice Spine, LP. | Choice Spine Navigation System | 01/08/2019 |
| K203561 | ChoiceSpine, LLC | ChoiceSpine Navigation System | 01/04/2021 |
| K220024 | ChoiceSpine, LLC | ChoiceSpine Navigation System | 07/06/2022 |
| K202956 | Clariance, SAS | Erisma LP Navigated Instruments | 02/26/2021 |
| K182731 | Corelink LLC | Corelink Navigation Instruments | 12/13/2019 |
| K212825 | CoreLink, LLC | CoreLink Navigation Instruments | 10/13/2021 |
| K214059 | CoreLink, LLC | CoreLink Navigation Instruments | 01/19/2022 |
| K220973 | CoreLink, LLC | CoreLink Navigation Instruments | 06/01/2022 |
| K230880 | CoreLink, LLC | CoreLink Navigation Instruments | 05/02/2023 |
| K232116 | CoreLink, LLC | CoreLink Navigation Instruments | 08/16/2023 |
| K200888 | Corin Ltd. | OMNIBotics Knee System | 06/27/2020 |
| K203751 | Corin USA | OMNIVision system | 04/12/2021 |
| K231172 | Corin USA Limited | ApolloKnee | 07/26/2023 |
| K160385 | CRYPTYCH PTY LTD | Precision Screw | 07/27/2016 |
| K213491 | CTL Medical Corporation | Universal Pilot Guidance Instrument System | 05/12/2022 |
| K201569 | Curexo, Inc. | CUVIS-spine | 05/19/2021 |
| K222698 | Curexo, Inc. | CUVIS-spine | 10/07/2022 |
| K223558 | Curexo, Inc. | CUVIS-spine | 06/22/2023 |
| K223200 | Curiteva, Inc. | Curiteva Navigation System | 01/06/2023 |
| K203816 | DeGen Medical | DeGen Navigated Instrumentation | 04/02/2021 |
| K213918 | DeGen Medical | DeGen Navigated Instrumentation | 02/09/2022 |
| K202769 | DePuy Ireland UC | VELYSÖ Robotic-Assisted Solution | 01/14/2021 |
| K221028 | Ecential Robotics | SURGIVISIO Device | 07/06/2022 |
| K231886 | Ecential Robotics | SURGIVISIO Device | 07/27/2023 |
| K230876 | Enztec Limited | RI.KNEE Adjustable Tibia Cut Guide | 06/27/2023 |
| K140689 | EVERGREEN ORTHOPEDIC RESEARCH LAB | IKNEE DISTAL FEMORAL CUTTING GUIDE | 08/22/2014 |
| K131130 | EVERGREEN ORTHOPEDIC RESEARCH LAB | NAVIGATION PIN | 07/19/2013 |
| K223350 | Fusion Robotics, LLC | Remi Robotic Navigation System | 03/13/2023 |
| K223070 | Fusion Robotics, LLC | Remi Robotic Navigation System | 10/28/2022 |
| K171651 | Globus Medical Inc. | EXCELSIUS GPS | 08/16/2017 |
| K190653 | Globus Medical Inc. | ExcelsiusGPS | 04/09/2019 |
| K200047 | Globus Medical Inc. | ExcelsiusGPS Cranial 1.0 Module | 07/10/2020 |
| K191100 | Globus Medical Inc. | ExcelsiusGPS Spine 1.1 Interbody Module | 07/24/2019 |
| K211616 | Globus Medical Inc. | ExcelsiusHub | 08/25/2021 |
| K180690 | Globus Medical Inc. | Navigation Instruments | 06/25/2018 |
| K153203 | GLOBUS MEDICAL INC. | Navigation Instruments | 02/03/2016 |
| K220774 | Hangzhou Lancet Robotics Co., Ltd. | RobPath« Total Hip Application | 12/09/2022 |
| K230861 | Icotec ag | VADER« Pedicle System Navigated Instruments | 06/27/2023 |
| K223511 | Innovasis, Inc. | Excella Navigation Instruments | 05/02/2023 |
| K203115 | Insight Medical Systems Inc. | ARVIS Surgical Navigation System | 07/14/2021 |
| K180523 | Intai Technology Corporation | INTAI Surgery Navigation System | 09/20/2019 |
| K212088 | Integrity Implants Inc. | Integrity Implants Navigated Instruments | 12/23/2021 |
| K133759 | INTELLIJOINT SURGICAL INC. | INTELLIJOINT HIP | 07/23/2014 |
| K162364 | INTELLIJOINT SURGICAL INC. | Intellijoint HIP Generation 2A System | 03/02/2017 |
| K171525 | Intellijoint Surgical Inc. | Intellijoint HIP Generation 2B System | 10/30/2017 |
| K172849 | Intellijoint Surgical Inc. | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | 11/16/2017 |
| K151364 | INTELLIJOINT SURGICAL INC. | Intellijoint HIP(tm) System | 12/28/2015 |
| K191507 | Intellijoint Surgical Inc. | Intellijoint« Navigation System | 10/01/2019 |
| K191012 | IZI Medical Products LLC | Navigated Pedicle Access Kit | 08/07/2019 |
| K192663 | joimax GmbH | Joimax Intracs System | 07/30/2020 |
| K181890 | K2M | Brainlab Compatible K2M Navigation Instruments | 11/09/2018 |
| K171321 | K2M | K2M Navigation Instruments | 08/30/2017 |
| K171556 | K2M | K2M Navigation Instruments | 01/16/2018 |
| K192911 | K2M, Inc. | Brainlab Compatible K2M Navigation Instruments | 11/14/2019 |
| K201006 | K2M, Inc. | K2M Navigation Instruments | 08/07/2020 |
| K213380 | Kico Knee Innovation Company Pty Limited | 360CAS | 01/11/2022 |
| K223927 | Kico Knee Innovation Company Pty Limited | 360CAS | 01/27/2023 |
| K202836 | Life Spine Inc. | GX Navigation Instrument System | 08/19/2021 |
| K170584 | MAKO Surgical Corp. | Mako Partial Knee Application | 05/11/2017 |
| K170891 | MAKO Surgical Corp. | Mako Partial Knee Application | 05/24/2017 |
| K172301 | MAKO Surgical Corp. | Mako Partial Knee Application | 11/02/2017 |
| K093425 | MAKO SURGICAL CORP. | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA | 02/24/2010 |
| K083644 | MAKO SURGICAL CORP. | MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP | 06/19/2009 |
| K170593 | MAKO Surgical Corp. | Mako Total Hip Application | 04/18/2017 |
| K193128 | Mako Surgical Corp. | Mako Total Hip Application | 02/02/2020 |
| K191998 | MAKO Surgical Corp. | Mako Total Hip Application, Mako Total Knee Application | 09/24/2019 |
| K170581 | MAKO Surgical Corp. | Mako Total Knee Application | 05/11/2017 |
| K193515 | Mako Surgical Corp. | Mako Total Knee Application | 07/14/2020 |
| K172219 | MAKO Surgical Corp. | Mako Total Knee Application | 09/21/2017 |
| K220459 | Mako Surgical Corp. | Mako Total Knee Application | 04/15/2022 |
| K091998 | MAKO SURGICAL CORP. | ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP | 09/28/2009 |
| K143752 | MAKO SURGICAL CORP. | Total Knee Application (TKA) | 08/06/2015 |
| K141989 | MAKO SURGICAL CORPORATION | MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM | 11/13/2014 |
| K121064 | MAKO SURGICAL CORPORATION | MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM | 06/06/2012 |
| K142530 | MAKO SURGICAL CORPORATION | Partial Knee Application (PKA) | 09/16/2015 |
| K112507 | MAKO SURGICAL CORPORATION | RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM | 03/01/2012 |
| K140167 | MAZOR ROBOTICS LTD | RENAISSANCE X SYSTEM | 09/10/2014 |
| K172522 | Mazor Robotics Ltd. | Mazor X | 09/15/2017 |
| K180307 | Mazor Robotics Ltd. | Mazor X | 04/30/2018 |
| K200935 | Mazor Robotics Ltd. | Mazor X | 05/08/2020 |
| K203005 | Mazor Robotics Ltd. | Mazor X | 10/27/2020 |
| K163221 | Mazor Robotics Ltd. | Mazor X | 04/04/2017 |
| K230064 | Mazor Robotics Ltd. | Mazor X System (Mazor X Stealth Edition) | 04/07/2023 |
| K182077 | Mazor Robotics Ltd. | Mazor X System (Mazor X Stealth Edition) | 11/02/2018 |
| K152041 | Mazor Robotics Ltd. | Renaissance X System | 11/17/2015 |
| K223769 | Medacta International S.A. | NextARÖ Spine Platform | 07/21/2023 |
| K213751 | Medacta International S.A. | NextARÖ TKA Platform My Knee PPS | 03/10/2022 |
| K210153 | Medacta International SA | NextAR RSA Platform | 05/12/2021 |
| K202152 | Medacta International SA | NextAR TKA Platform | 10/27/2020 |
| K083872 | MEDACTA INTERNATIONAL, SA | IMNS MEDACTA NAVIGATION SYSTEM | 01/15/2009 |
| K210859 | Medacta International, SA | NextARÖ Spine Platform | 11/05/2021 |
| K231527 | Medos International S└RL | TriALTIS Navigation Enabled Instruments | 09/29/2023 |
| K212756 | MEDOS International SARL | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | 05/05/2022 |
| K140927 | MEDOS INTERNATIONAL SARL | UNIVERSAL NAVIGATION INSTRUMENTS | 10/24/2014 |
| K120867 | MEDOS INTERNATIONAL SARL | VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS | 09/20/2012 |
| K200791 | Medos International, SARL | Navigation Enabled Intruments | 07/31/2020 |
| K201661 | Medos International, SARL | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | 09/16/2020 |
| K191943 | Medos International, SARL | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set | 10/18/2019 |
| K223108 | Medos International, SARL | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) | 01/19/2023 |
| K170937 | Medos International, SARL | VIPER PRIME navigated inserter | 09/14/2017 |
| K182848 | Medtech S.A. | ROSA ONE Spine application | 03/22/2019 |
| K192173 | MEDTECH S.A. | ROSA ONE Spine application | 10/29/2019 |
| K151511 | MEDTECH S.A. | ROSA Spine | 01/04/2016 |
| K211596 | Medtronic | CD Horizon Spinal System | 06/23/2021 |
| K171267 | Medtronic Navigation | NavLock Trackers | 07/03/2017 |
| K201327 | Medtronic Navigation | NavLock Trackers | 06/18/2020 |
| K182104 | Medtronic Navigation | NavLock Trackers, Robotic Reference Frame | 11/02/2018 |
| K170011 | MEDTRONIC NAVIGATION | StealthStation S8 Spine Software v1.0.0 | 05/01/2017 |
| K211442 | Medtronic Navigation | StealthStation Spinous Process Clamps | 07/08/2021 |
| K180816 | Medtronic Navigation | Ziehm RFD 3D Tracker | 07/11/2018 |
| K131425 | MEDTRONIC NAVIGATION, INC. | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER | 08/14/2013 |
| K124004 | MEDTRONIC NAVIGATION, INC. | NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS | 03/22/2013 |
| K201189 | Medtronic Navigation, Inc. | Stealthstation S8 Spine Software v1.3.0 | 05/29/2020 |
| K183644 | Medtronic Powered Surgical Solutions | Stealth-Midas MR8 System | 05/22/2019 |
| K160713 | MEDTRONIC POWERED SURGICAL SOLUTIONS | Stealth-Midas System | 05/26/2016 |
| K202552 | Medtronic Powered Surgical Solutions (MPSS) | Midas Rex Attachments and Dissecting Tools | 11/02/2020 |
| K230716 | Medtronic Sofamor Danek Inc | Robotic Graft Delivery Instruments | 07/18/2023 |
| K221180 | Medtronic Sofamor Danek USA, INC | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | 05/25/2022 |
| K150231 | MEDTRONIC SOFAMOR DANEK USA, INC | Navigated Disc Prep Instruments and CAPSTONE Trials | 06/16/2015 |
| K163581 | MEDTRONIC SOFAMOR DANEK USA, INC | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | 04/14/2017 |
| K143628 | MEDTRONIC SOFAMOR DANEK USA, INC | Navigated Vertex Select Instruments | 02/12/2015 |
| K222383 | Medtronic Sofamor Danek USa, Inc. | AnteralignÖ LS Spinal System with Titan nanoLOCKÖ Surface Technology MAZORX Stealth(TM) Edition | 09/29/2022 |
| K214011 | Medtronic Sofamor Danek USA, INC. | CatalyftÖ PL Expandable Interbody System Navigated Instruments, AnteralignÖ TL Spinal System with Titan nanoLOCKÖ Surface Technology Navigated Instruments, and CD HorizonÖ SoleraÖ VoyagerÖ Spinal System Navigated, Guided, and Powered Drivers | 02/09/2022 |
| K203291 | Medtronic Sofamor Danek USA, INC. | CD Horizon Spinal System Instruments | 12/08/2020 |
| K182121 | Medtronic Sofamor Danek USA, Inc. | CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition | 11/02/2018 |
| K192336 | Medtronic Sofamor Danek USA, INC. | Navigated Anterolateral Disc Prep Instruments | 11/22/2019 |
| K211441 | Medtronic Sofamor Danek USA, INC. | Navigated Anterolateral Disc Prep Instruments | 06/09/2021 |
| K140454 | MEDTRONIC SOFAMOR DANEK USA, INC. | NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS | 05/22/2014 |
| K181111 | Medtronic Sofamor Danek USA, Inc. | Navigated INFINITY Instruments | 05/17/2018 |
| K173338 | Medtronic Sofamor Danek USA, Inc. | Navigated INFINITYÖ Instruments | 01/18/2018 |
| K191039 | Medtronic Sofamor Danek, USA Inc | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | 08/26/2019 |
| K231184 | Medtronic Sofamor Danek, USA Inc. | CD HorizonÖ Spinal System | 05/26/2023 |
| K213873 | MicroPort NaviBot International LLC | SkyWalker Total Knee System | 07/07/2022 |
| K230369 | MiRus LLC | EUROPAÖ Navigated Instruments | 06/23/2023 |
| K182524 | MiRus, LLC | GALILEO Spine Alignment Monitoring System | 06/17/2019 |
| K200376 | Navbit Pty Ltd | Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration | 12/10/2020 |
| K193094 | Naviswiss AG | Naviswiss Hip Navigation System | 06/10/2020 |
| K223351 | Naviswiss AG | Naviswiss Knee | 01/31/2023 |
| K220291 | Nexxt Spine LLC | NEXXT SPINE NAVIGATION System | 03/31/2022 |
| K220146 | Novarad Corporation | VisAR | 05/27/2022 |
| K111811 | NUVASIVE, INC. | BENDINI(TM) SPINAL ROD BENDING SYSTEM | 12/05/2011 |
| K122742 | NUVASIVE, INC. | NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM | 12/07/2012 |
| K172623 | NuVasive, Incorporated | NuVasive Navigation Instruments | 12/21/2017 |
| K200719 | NuVasive, Incorporated | NuVasive Navigation.S Instruments | 12/02/2020 |
| K180038 | NuVasive, Incorporated | NuVasive Pulse System | 06/29/2018 |
| K210574 | NuVasive, Incorporated | NuVasive Pulse System | 07/29/2021 |
| K230989 | NuVasive, Incorporated | Rod Registration Frame | 05/05/2023 |
| K163338 | OMNllife Science Inc. | OMNIBotics Knee System | 09/01/2017 |
| K231284 | OnPoint Surgical, Inc. | OnPoint Augmented Reality Spine System | 09/08/2023 |
| K200892 | OrthAlign Inc | Harvey(R) Surgical Assistant | 06/18/2020 |
| K091411 | ORTHALIGN, INC | KNEEALIGN SYSTEM | 09/25/2009 |
| K103829 | ORTHALIGN, INC | KNEEALIGN SYSTEM | 04/04/2011 |
| K093998 | ORTHALIGN, INC | KNEEALIGN SYSTEM WITH REFERENCE SENSOR | 03/22/2010 |
| K140331 | ORTHALIGN, INC | ORTHALIGN PLUS SYSTEM | 06/10/2014 |
| K130387 | ORTHALIGN, INC | ORTHOALIGN PLUS SYSTEM | 11/08/2013 |
| K163379 | OrthAlign, Inc. | KneeAlign 2 System | 03/02/2017 |
| K153237 | OrthAlign, Inc. | OrthAlign Plus System | 03/01/2016 |
| K162962 | OrthAlign, Inc. | OrthAlign Plus System | 01/23/2017 |
| K171780 | OrthAlign, Inc. | OrthAlign Plus System | 07/11/2017 |
| K172462 | OrthAlign, Inc. | OrthAlign Plus System | 11/22/2017 |
| K200642 | OrthAlign, Inc. | OrthAlign Plus System | 04/10/2020 |
| K162921 | ORTHOFIX INC. | Navigated Instrument System | 03/13/2017 |
| K172115 | Orthofix Inc. | Navigated Instrument System | 03/08/2018 |
| K192653 | Orthokey Italia S.r.l. | Perseus | 09/09/2020 |
| K203573 | OrthoPediatrics, Corp. | RESPONSE Navigation Instruments | 02/04/2021 |
| K213033 | Orthosoft d/b/a Zimmer CAS | iASSIST Knee System | 01/14/2022 |
| K210121 | Orthosoft d/b/a Zimmer CAS | ROSA Partial Knee System | 04/19/2021 |
| K221928 | Orthosoft d/b/a Zimmer CAS | ROSA« Knee System | 10/04/2022 |
| K230243 | Orthosoft d/b/a Zimmer CAS | ROSA« Knee System | 03/29/2023 |
| K192080 | Orthosoft Inc. (d/b/a Zimmer CAS) | iASSIST Knee System | 11/05/2019 |
| K230567 | Orthosoft Inc. (d/b/a Zimmer CAS) | OptiVuÖ ROSA« MxR | 06/13/2023 |
| K182964 | Orthosoft Inc. (d/b/a Zimmer CAS) | ROSA Knee System | 01/24/2019 |
| K230180 | Orthosoft, Inc (d/b/a Zimmer CAS) | Rosa Knee System | 02/22/2023 |
| K213708 | Orthosoft, Inc (d/b/a Zimmer CAS) | ROSA« Knee System | 04/22/2022 |
| K100599 | ORTHOSOFT, INC. | CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM | 04/05/2010 |
| K181449 | Ortoma AB | Ortoma Treatment Solution - OTS | 09/19/2018 |
| K192495 | Osseus Fusion Systems | Black Diamond Navigation Instruments | 01/17/2020 |
| K222355 | PathKeeper Surgical LTD | PathKeeper System | 03/08/2023 |
| K111443 | PINSCO INC. DBA B & L ENGINEERING | X12 STERILE REFLECTIVE MARKER SPHERE | 09/29/2011 |
| K200095 | Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. | Streamline Navigated Instruments | 06/26/2020 |
| K230789 | Pixee Medical | Knee+ | 04/21/2023 |
| K202750 | Pixee Medical | Knee+ | 04/21/2021 |
| K220104 | Pixee Medical | Knee+ | 09/01/2022 |
| K230087 | Point Robotics Medtech Inc. | ôPOINTö Kinguide Agile Hybrid Navigation System | 07/17/2023 |
| K220241 | Point Robotics MedTech Inc. | ôPOINTö Kinguide Robotic-Assisted Surgical System | 08/09/2022 |
| K202184 | Practical Navigation, LLC | Practical Navigation Surgical Guidance System (PNSGS) | 02/24/2021 |
| K090953 | PRAXIM MEDIVISION, SA | TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK | 01/21/2010 |
| K220862 | Precision Spine, Inc. | E-GPS Navigated Instruments | 07/14/2022 |
| K181606 | Precision Spine, Inc. | Precision Spine Navigation Instrumentation | 09/27/2019 |
| K231229 | Precision Spine, Inc. | S-COMP Reform« POCT Navigation Instruments | 05/25/2023 |
| K191854 | Premia Spine, Ltd. | Premia Spine XL Instruments | 10/08/2019 |
| K222291 | Proprio, Inc. | Paradigm System | 04/21/2023 |
| K230783 | Remex Medical Corp. | Anatase Spine Surgery Navigation System | 04/21/2023 |
| K220348 | Remex Medical Corporation | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V | 07/14/2022 |
| K212028 | Republic Spine, LLC | Dark Star Navigation Instrument System | 09/27/2021 |
| K222753 | SeaSpine Orthopedics Corporation | SeaSpine 7D Navigation Instruments | 12/09/2022 |
| K172517 | SeaSpine Orthopedics Corporation | SeaSpine Navigation System | 05/11/2018 |
| K203110 | SI-BONE, Inc. | iFuse Implant System - iFuse Navigation | 11/09/2020 |
| K172268 | SI-BONE, Inc. | iFuse Implant System- iFuse Navigation | 10/31/2017 |
| K212007 | Silony Medical GmbH | VERTICALE Navigation Instruments | 08/12/2021 |
| K223649 | Silony Medical GmbH | VERTICALE« Navigation Instruments | 12/22/2022 |
| K111843 | SMITH & NEPHEW INC., ENDOSCOPY DIV. | ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM | 11/14/2011 |
| K090313 | SMITH & NEPHEW, INC. | PIGALILEO TKR BASE V2.3 AND CAS V4.1 | 03/11/2009 |
| K090420 | SMITH & NEPHEW, INC. | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0 | 05/27/2009 |
| K092497 | SMITH & NEPHEW, INC. | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 | 09/11/2009 |
| K100107 | SMITH & NEPHEW, INC. | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 | 02/23/2010 |
| K130748 | SMITH & NEPHEW, INC. | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 | 08/04/2013 |
| K170280 | Smith & Nephew, Inc. | Smith & Nephew SURESHOT Distal Targeting System V4.0 | 04/28/2017 |
| K180277 | Smith & Nephew, Inc. | Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter | 04/24/2018 |
| K110240 | SMITH & NEPHEW, INC. | SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 | 04/14/2011 |
| K170977 | Smith & Nephew, Inc. | SURESHOT Distal Targeting System V4.0 Trauma Interface | 05/03/2017 |
| K102967 | SMITH & NEWPHEW, INC | SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 | 11/04/2010 |
| K190881 | Spinal Elements Inc | Spinal Elements Navigated Instruments | 12/19/2019 |
| K181596 | Spine Wave, Inc. | Spine Wave Navigated Instruments | 10/24/2018 |
| K192526 | Spine Wave, Inc. | Spine Wave Navigated Instruments | 10/10/2019 |
| K210472 | Spineart | SPINEART Navigation Instrument System | 03/19/2021 |
| K183630 | Spineart SA | SPINEART Navigation Instrument System | 06/10/2019 |
| K223301 | SpineCraft, LLC | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System | 07/20/2023 |
| K182345 | Spineology Inc | Spineology Navigation Instruments | 09/21/2018 |
| K172518 | Spineology Inc. | Spineology Navigation Instruments | 01/05/2018 |
| K180796 | Spineology Inc. | Spineology Navigation Instruments | 05/02/2018 |
| K213876 | Spineology Inc. | Spineology Navigation Instruments | 08/05/2022 |
| K121765 | STANMORE IMPLANTS WORLDWIDE LTD | SCULPTOR ROBOTIC GUIDANCE ARM (RGA) | 01/11/2013 |
| K183381 | STRYKER | Navigation Enabled Instruments | 05/17/2019 |
| K093206 | STRYKER CORP. | ORTHOMAP 3D 1.1 MODULE | 08/04/2010 |
| K143597 | STRYKER CORPORATE | Navigated XIA 4.5 Polyaxial Screwdriver | 09/04/2015 |
| K141941 | STRYKER CORPORATE | SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D | 10/31/2014 |
| K153240 | STRYKER CORPORATE | Styrker OrthoMap Express Knee System | 07/07/2016 |
| K103400 | STRYKER CORPORATION | FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP | 03/07/2011 |
| K183196 | Stryker Corporation | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker | 02/14/2019 |
| K162937 | Stryker Corporation | Stryker OrthoMap Versatile Hip System | 02/23/2017 |
| K172034 | Stryker Corporation | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap | 10/18/2017 |
| K202749 | Stryker GmbH | ADAPT for Gamma3 | 12/18/2020 |
| K173946 | Stryker GmbH | ADAPT for Gamma3 | 05/02/2018 |
| K181848 | Stryker GMBH | ADAPT for Gamma3, Gamma3 | 10/12/2018 |
| K223767 | Stryker Leibinger GmbH & Co. KG | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System | 02/13/2023 |
| K083009 | Stryker Leibinger GmbH & Co. KG | ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 | 02/19/2009 |
| K220593 | Stryker Leibinger GmbH & Co. KG | Spine Guidance Software, Stryker Q Guidance System | 05/27/2022 |
| K162341 | Stryker Leibinger GmbH & Co. KG | Stryker OrthoMap Precision Knee system | 10/12/2016 |
| K203205 | Stryker Spine | Navigated Spine Instruments | 03/23/2021 |
| K211254 | Surgalign Spine Technologies | ARAI Surgical Navigation System | 01/14/2022 |
| K231611 | Surgalign Spine Technologies | HOLO PortalÖ Surgical Guidance System | 08/31/2023 |
| K213034 | Surgical Theater, Inc. | SpineAR SNAP | 09/29/2022 |
| K220554 | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Caduceus S | 12/16/2022 |
| K162195 | THINK SURGICAL INC. | TSolution One Cup1 Surgical System | 09/14/2016 |
| K170430 | THINK Surgical Inc. | TSolution One Surgical System Model 210 | 03/06/2017 |
| K153647 | THINK SURGICAL INC. | TSolution One w/ACG+ Surgical System | 02/16/2016 |
| K230202 | THINK Surgical, Inc. | TMINIÖ Miniature Robotic System | 04/25/2023 |
| K191369 | THINK Surgical, Inc. | TSolution One Total Knee Application | 10/08/2019 |
| K193135 | Think Surgical, Inc. | TSolution One Total Knee Application | 12/11/2019 |
| K203040 | THINK Surgical, Inc. | TSolution One Total Knee Application | 11/13/2020 |
| K210668 | THINK Surgical, Inc. | TSolution One Total Knee Application | 04/01/2021 |
| K201255 | THINK Surgical, Inc. | TSolution« One Total Knee Application | 06/10/2020 |
| K222510 | Tornier SAS | Blueprint Mixed Reality system | 01/20/2023 |
| K200845 | ulrich medical USA | Navigation Module of the Momentum System | 09/10/2020 |
| K223808 | Zavation Medical Products, LLC | Zavation Navigation Instrument System | 07/12/2023 |
| K122326 | ZIMMER | SMARTTOOLS KNEE SYSTEM | 11/30/2012 |
| K212023 | Zimmer Biomet Spine, Inc. | Virage Navigation System | 08/27/2021 |
| K191722 | Zimmer Biomet Spine, Inc. | Vital Navigation System | 12/02/2019 |
| K192133 | Zimmer Biomet Spine, Inc. | Zimmer Biomet Universal Navigation System | 10/29/2019 |
| K190556 | Zimmer Biomet Spine, Inc. | Zimmer Biomet Universal Navigation System | 10/24/2019 |
| K141601 | ZIMMER CAS | IASSIST KNEE SYSTEM | 09/11/2014 |
| K110054 | ZIMMER CAS | NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE | 03/24/2011 |
| K213720 | ZimVie (Zimmer Biomet Spine, Inc.) | Vital Navigation System | 01/07/2022 |
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