FDA 510(k) Applications for Medical Device Product Code "NKG"
(Orthosis, Cervical Pedicle Screw Spinal Fixation)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K151938 | AESCULAP IMPLANT SYSTEMS, LLC | S4 Cervical Spinal and Occiput Systems | 10/21/2015 |
| K213871 | Aesculap Implant Systems, LLC. | Ennovate Cervical Spinal and Occiput System | 07/01/2022 |
| K191185 | Alphatec Spine | Solanas« Posterior OCT Fixation System | 06/03/2019 |
| K200936 | Alphatec Spine, Inc. | InvictusÖ CT Spinal Fixation System | 05/22/2020 |
| K203125 | Alphatec Spine, Inc. | InvictusÖ OCT Spinal Fixation System | 12/18/2020 |
| K210887 | Altus Partners, LLC | Altus Spine Sochi OCT Spinal System | 08/20/2021 |
| K171250 | Astura Medical | BRIDALVEIL Occipital Cervical Thoracic System | 10/02/2017 |
| K151224 | BIOMET SPINE | Lineum OCT Spine System | 06/30/2015 |
| K152211 | CENTINEL SPINE, INC. | PCT System | 12/01/2015 |
| K200863 | CoreLink, LLC | Tiger« Occipital-Cervical-Thoracic Spinal Fixation System | 04/28/2020 |
| K151885 | DEPUY SYNTHES, Inc. | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | 09/03/2015 |
| K160697 | Exactech, Inc. | Gibralt« Spine System and Gibralt« Occipital Spine System | 06/28/2016 |
| K171834 | G Surgical LLC | G Surgical OCT Spinal System | 12/19/2017 |
| K150552 | GLOBUS MEDICAL INC. | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | 06/04/2015 |
| K211957 | Globus Medical Inc. | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | 08/18/2021 |
| K161591 | GLOBUS MEDICAL INC. | QUARTEXÖ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | 09/21/2016 |
| K192354 | Innovasis, Inc. | Innovasis Gibralt Spine System | 09/24/2019 |
| K182182 | K2M | YUKON OCT Spinal System | 11/15/2018 |
| K181603 | K2M Inc. | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System | 10/05/2018 |
| K171444 | K2M, Inc. | YUKON OCT Spinal System | 08/08/2017 |
| K193129 | K2M, Inc. | Yukon OCT Spinal System | 02/07/2020 |
| K153370 | K2M, Incorporated | Caspian OCT/MESA Mini/DENALI Mini Spinal System | 02/16/2016 |
| K231840 | L & K Biomed Co., Ltd. | CastleLoc-S Posterior Cervical Fixation System | 07/20/2023 |
| K200793 | L&K BIOMED Co., Ltd. | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System | 10/08/2020 |
| K153439 | L&K BIOMED CO., LTD. | PathLoc-C Posterior Cervical Fixation System | 07/21/2016 |
| K162136 | L&K BIOMED CO.,LTD. | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System | 11/03/2016 |
| K200896 | Life Spine Inc. | Solstice CCI | 04/28/2020 |
| K162266 | LIFE SPINE INC. | The Cranial Fusion System | 05/01/2017 |
| K170804 | Life Spine Inc. | The Solstice OCT System | 05/18/2017 |
| K173047 | Life Spine, Inc. | The Solstice OCT System | 02/01/2018 |
| K220570 | Medacta International S.A. | M.U.S.T. MINI Posterior Cervical Screws System Extension | 04/26/2022 |
| K182837 | Medacta International SA | M.U.S.T. Mini Extension | 01/22/2019 |
| K171369 | Medacta International SA | M.U.S.T. MINI Posterior Cervical Screws System | 08/01/2017 |
| K190631 | Medacta International SA | M.U.S.T. MINI Posterior Cervical Screws System | 04/10/2019 |
| K200130 | Medacta International SA | M.U.S.T. MINI Posterior Cervical Screws System | 02/10/2020 |
| K203149 | Medacta International SA | M.U.S.T. MINI Posterior Cervical Screws System | 11/16/2020 |
| K220810 | Medicrea International | InfinityÖ OCT System and PASS OCT Spinal System | 04/19/2022 |
| K153169 | MEDICREA INTERNATIONAL | PASS OCT Patient Specific Rods | 01/29/2016 |
| K161149 | MEDICREA INTERNATIONAL S.A | PASS OCT Spinal System | 07/11/2016 |
| K150918 | MEDICREA INTERNATIONAL S.A. | PASS OCT Spinal System | 10/16/2015 |
| K160756 | MEDICREA INTERNATIONAL S.A. | PASS OCT Spinal System | 04/26/2016 |
| K190895 | Medos International Sarl | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System | 07/18/2019 |
| K203319 | Medos International Sarl | SYMPHONYÖ OCT System | 02/05/2021 |
| K181949 | Medos International SARL | SYMPHONYÖ OCT System | 10/04/2018 |
| K192646 | Medos International SARL | SYMPHONYÖ OCT System | 04/02/2020 |
| K192014 | Medos International SARL | SYPMHONYÖ OCT System | 01/24/2020 |
| K210449 | Medtronic | InfinityÖ OCT System, PASS OCT« Spinal System | 03/18/2021 |
| K143471 | Medtronic Sofamor Danek USA, Inc | VERTEX Reconstruction System | 02/06/2015 |
| K152338 | MEDTRONIC SOFAMOR DANEK USA, INC | VERTEX(r) Reconstruction System | 10/28/2015 |
| K180851 | Medtronic Sofamor Danek USA, Inc | VERTEXÖ Reconstruction System | 04/18/2018 |
| K223764 | Medtronic Sofamor Danek USA, Inc. | INFINITY OCT System | 01/11/2023 |
| K163375 | Medtronic Sofamor Danek USA, Inc. | INFINITYÖ OCT System | 08/21/2017 |
| K161637 | Medyssey USA, Inc. | Poseidon OCT Spinal Fixation System | 01/05/2017 |
| K182508 | Nexxt Spine LLC | SaxxonyÖ Posterior Cervical Thoracic System | 11/13/2018 |
| K191553 | NuVasive, Incorporated | NuVaisve« Reline« Cervical System | 08/14/2019 |
| K221388 | NuVasive, Incorporated | NuVasive Reline Cervical System | 09/09/2022 |
| K213654 | NuVasive, Incorporated | NuVasive Reline Cervical System | 02/23/2022 |
| K150474 | NuVasive, Incorporated | NuVasive VuePoint II OCT System | 10/21/2015 |
| K180198 | NuVasive, Incorporated | NuVasive« VuePoint« II OCT System | 03/15/2018 |
| K153336 | NUVASIVE, INCORPORATED | VuePoint OCT System | 01/07/2016 |
| K211710 | Orthofix Inc. | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screw | 07/30/2021 |
| K180025 | Orthofix Inc. | Centurion POCT System | 01/22/2018 |
| K201481 | Orthofix Inc. | Centurion POCT System | 06/15/2020 |
| K170647 | Orthofix Inc. | Connector System | 05/11/2017 |
| K172194 | Orthofix Inc. | Connector System | 08/18/2017 |
| K190751 | Orthofix Inc. | Connector System | 05/22/2019 |
| K150822 | ORTHOFIX, INC. | Centurion POCT System | 05/15/2015 |
| K222107 | Osseus Fusion Systems | Black DiamondÖ POCT Spinal System | 11/03/2022 |
| K161498 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) | Streamline OCT Occipito-Cervico-Thoracic System | 08/22/2016 |
| K172139 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) | Streamline OCT Occipito-Cervico-Thoracic System | 08/18/2017 |
| K162300 | PRECISION SPINE, INC. | Reform« POCT System | 11/22/2016 |
| K172495 | Precision Spine, Inc. | Reform« POCT System | 04/11/2018 |
| K172279 | Providence Medical Technology, Inc. | PMT Posterior Fixation System | 09/20/2017 |
| K231654 | SeaSpine Inc. | NorthStar OCT System | 08/03/2023 |
| K193615 | SeaSpine Orthopedics Corporation | NorthStarÖ OCT Spinal System | 03/25/2020 |
| K220658 | SIGNUS Medizintechnik GmbH | COSY Cervicothoracic Occipital Rod-Screw System | 11/18/2022 |
| K192013 | Silony Medical GmbH | VERTICALE« Cervical System | 04/07/2020 |
| K151705 | SPINAL ELEMENTS, INC. | Lotus Posterior Cervical/Thoracic Spinal System | 09/03/2015 |
| K221307 | Spinal Simplicity LLC | Edge Upper Cervical System | 07/10/2023 |
| K172594 | Spine Wave, Inc. | Proficient« Posterior Cervical Spine System | 12/15/2017 |
| K181440 | Spine Wave, Inc. | Proficient« Posterior Cervical Spine System | 07/30/2018 |
| K162639 | Spine Wave, Inc. | ProficientÖ Posterior Cervical Spine System | 02/07/2017 |
| K153386 | SPINEART | Perla Posterior Cervico-Thoracic Fixation system | 01/25/2016 |
| K190071 | SPINEART | Perla« Posterior Cervico-Thoracic Fixation System | 02/25/2019 |
| K200571 | SPINEART | PERLA« Posterior Occipito-Cervico-Thoracic Fixation System | 05/01/2020 |
| K181350 | SpineCraft LLC | ASTRA-OCT Spine System | 07/06/2018 |
| K150539 | Stryker Corporation | OASYS System | 05/12/2015 |
| K151755 | Stryker Corporation | OASYS(r) System | 07/09/2015 |
| K142838 | SYNTHES USA PRODUCTS, LLC | Synapse Occipital-Cervical-Thoracic (OCT) System | 01/20/2015 |
| K183383 | U & I Corporation | ANAXÖ OCT Spinal System | 12/12/2018 |
| K150570 | U&I Corporation | ANAX OCT Spinal System | 06/03/2015 |
| K150650 | ULRICH GMBH & CO. KG | neon3 | 09/24/2015 |
| K161032 | ULRICH GMBH & CO. KG | neon3Ö universal OCT spinal stabilization | 12/22/2016 |
| K230614 | ulrich medical USA | CortiumÖ | 05/02/2023 |
| K213394 | Vy Spine, LLC | Vy SpineÖ VySpanÖ PCT System | 12/10/2021 |
| K223852 | Vy Spine, LLC | VySpanÖ PCT System | 02/24/2023 |
| K232167 | Vy Spine, LLC | VySpanÖ PCT System | 09/27/2023 |
| K160428 | X-spine Systems, Inc. | Certex Spinal Fixation System | 05/05/2016 |
| K161478 | Xenco Medical, LLC | Xenco Medical Posterior Cervical System | 09/06/2016 |
| K211993 | Zavation Medical Products LLC | Z-LINKPC System | 08/11/2021 |
| K162575 | ZAVATION, LLC | Z-LINKPC System | 03/03/2017 |
| K151031 | ZIMMER SPINE, INC | Virage OCT Spinal Fixation System | 06/24/2015 |
| K153631 | Zimmer Spine, Inc | Zimmer Virage OCT Spinal Fixation System | 02/16/2016 |
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