FDA 510(k) Applications Submitted by STRYKER CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K160715 03/15/2016 AccuLIF TL and PL Cage STRYKER CORPORATION
K152651 09/16/2015 AccuLIF TL and PL Cage STRYKER CORPORATION
K143616 12/19/2014 AccuLIF TL and PL Cage STRYKER CORPORATION
K142066 07/30/2014 AERO-LL LUMBAR CAGE SYSTEM STRYKER CORPORATION
K201585 06/11/2020 Monterey AL Interbody System Stryker Corporation
K210377 02/09/2021 Stryker iBur hubs and cutting accessories Stryker Corporation
K172034 07/05/2017 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 Stryker Corporation
K183196 11/19/2018 Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker Stryker Corporation
K170242 01/26/2017 MultiGenÖ 2 RF Generator System STRYKER CORPORATION
K162062 07/26/2016 AVAmax Vertebral Balloon, AVAflex Vertebral Balloon STRYKER CORPORATION
K162937 10/20/2016 Stryker OrthoMap Versatile Hip System Stryker Corporation
K141673 06/23/2014 IVAS 8 GAUGE BONE BIOPSY KIT STRYKER CORPORATION
K162929 10/19/2016 Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker Stryker Corporation
K221074 04/12/2022 OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device Stryker Corporation
K212194 07/14/2021 Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precisi Stryker Corporation
K121664 06/05/2012 T4/T5 HYTREL TOGAS STRYKER CORPORATION
K202964 09/30/2020 iBed Wireless with iBed Mobile Stryker Corporation
K130430 02/20/2013 IVAS 10MM AND 15MM BALLOON CATHETER STRYKER CORPORATION
K123942 12/20/2012 STRYKER IVAS BALLOON CATHETER STRYKER CORPORATION
K200493 02/28/2020 Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover Stryker Corporation
K103292 11/08/2010 TRIO TRAUMA SPINAL SYSTEM STRYKER CORPORATION
K150801 03/26/2015 Stryker Maestro Air Motors STRYKER CORPORATION
K152641 09/15/2015 Pi Drive Plus Motor, Extender STRYKER CORPORATION
K103536 12/01/2010 IBED WIRELESS WITH IBED AWARENESS STRYKER CORPORATION
K103124 10/22/2010 SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS STRYKER CORPORATION
K212055 07/01/2021 Connected OR Hub with Device and Voice Control Stryker Corporation
K150753 03/23/2015 OASYS System STRYKER CORPORATION
K151726 06/26/2015 AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer Stryker Corporation
K151755 06/29/2015 OASYS(r) System Stryker Corporation
K142251 08/14/2014 AVS AS PEEK Spacer Stryker Corporation
K142741 09/24/2014 OASYS System STRYKER CORPORATION
K143163 11/03/2014 AVS« AL and ALign PEEK Spacers, AVS« PL and UniLIF PEEK Spacers, AVS« TL PEEK Spacer, AVS« Navigator PEEK Spacer, AVS« ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS« Anchor-L Spacer, Aero-AL Lumbar Cage System STRYKER CORPORATION
K142114 08/04/2014 Xia« Growth Rod Conversion Set STRYKER CORPORATION
K150539 03/03/2015 OASYS System Stryker Corporation
K200613 03/09/2020 Tritanium« X TL Expandable Curved Posterior Lumbar Cage Stryker Corporation
K232157 07/20/2023 Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control Stryker Corporation
K161514 06/02/2016 Precision Thin Reciprocating Blade, 0.010in. STRYKER CORPORATION
K211490 05/13/2021 Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 Stryker Corporation
K190070 01/15/2019 Sonopet iQ Ultrasonic Aspirator System Stryker Corporation
K140588 03/07/2014 FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS STRYKER CORPORATION
K141095 04/28/2014 STRYKER STERI-SHIELD FLYTE HYBRID TOGAS STRYKER CORPORATION
K221728 06/14/2022 Aviator« Anterior Cervical Plating (ACP) System, LITe« Plate System, DynaTranÖ Anterior Cervical Plating (ACP) System, ReflexÖ Hybrid ACP System, UniViseÖ Spinous Process Fixation Plate Stryker Corporation
K153407 11/25/2015 Stryker Neptune 3 Waste Management System STRYKER CORPORATION
K141217 05/12/2014 ACCULIF TL AND PL CAGE STRYKER CORPORATION
K142699 09/22/2014 LITe Plate System STRYKER CORPORATION
K180327 02/06/2018 Stryker iVAS 13g Bone Biopsy Kit Stryker Corporation
K150582 03/09/2015 Vertaplex« High Viscosity (HV) Radiopaque Bone Cement STRYKER CORPORATION
K181752 07/02/2018 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation
K172116 07/13/2017 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation
K202393 08/21/2020 SpineJack Expansion Kit Stryker Corporation
K172558 08/24/2017 iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit Stryker Corporation
K192818 10/01/2019 Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System Stryker Corporation
K103400 11/19/2010 FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP STRYKER CORPORATION
K160693 03/14/2016 Neptune E-SEP Smoke Evacuation Pencil STRYKER CORPORATION
K143540 12/15/2014 Stryker MIS Attachments and Cutting Accessories STRYKER CORPORATION
K153679 12/21/2015 Stryker Neptune E-SEP Smoke Evacuation Pencil STRYKER CORPORATION
K140095 01/14/2014 PRIME ZOOM STRETCHER STRYKER CORPORATION
K221098 04/14/2022 Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit Stryker Corporation
K202609 09/09/2020 Instrument Clamps Electromagnetic Stryker Corporation
K113154 10/26/2011 IVAS BALLOON CATHETER STRYKER CORPORATION
K103807 12/29/2010 IVAS 2-10MM (10 GUAGE) BALLON CATHETER STRYKER CORPORATION
K170496 02/17/2017 Xia« 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory Stryker Corporation
K160978 04/07/2016 LITe BIO Delivery System STRYKER CORPORATION
K132671 08/27/2013 STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM STRYKER CORPORATION
K112593 09/07/2011 STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM STRYKER CORPORATION
K171840 06/20/2017 Stryker Consolidated Operating Room Equipment (CORE) 2 Console Stryker Corporation
K171807 06/19/2017 ES2 Neuromonitoring Accessory Instruments Stryker Corporation
K191049 04/19/2019 Stryker MIS and Footed Attachments Stryker Corporation
K172724 09/11/2017 XIA« 4.5 Spinal System, Power Adaptor Instrument Accessory Stryker Corporation
K160050 01/11/2016 SERFAS 90-S Electrosurgical Probe STRYKER CORPORATION
K151932 07/14/2015 Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing STRYKER CORPORATION
K140400 02/18/2014 ES2 NEUROMONITORING ACCESSORY INSTRUMENTS STRYKER CORPORATION
K142237 08/13/2014 Aviator Anterior Cervical Plate (ACP) System Stryker Corporation
K152632 09/15/2015 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory STRYKER CORPORATION
K143546 12/15/2014 Imbibe Aspirating XIA Taps Stryker Corporation
K213824 12/08/2021 Sonopet iQ Ultrasonic Aspirator System Stryker Corporation
K223770 12/15/2022 Sonopet 1Q 3 7cm 1Q Large Stryker Corporation
K111478 05/27/2011 STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT) STRYKER CORPORATION
K133328 10/29/2013 AERO-AL LUMBAR CAGE SYSTEM STRYKER CORPORATION
K150700 03/18/2015 ACP 1 Anterior Cervical Plating System STRYKER CORPORATION
K141935 07/17/2014 STRYKER S2 DRILL STRYKER CORPORATION


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