FDA Product Code
FDA Product Code NKG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3075
510(k) Clearances — 119 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254260 | The VEGA Cervical Screw System | GS Medical Co., Ltd. | 2026-09-17 | Traditional | PDF ↗ |
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-02 | Traditional | PDF ↗ |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | 2026-03-16 | Traditional | PDF ↗ |
| K254165 | Infinity OCT System | Medtronic Sofamor Danek USA, Inc. | 2026-01-21 | Special | PDF ↗ |
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025-11-12 | Traditional | PDF ↗ |
| K253129 | Infinity OCT System | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 | Special | PDF ↗ |
| K251725 | ANAX OCT Spinal System | Cg Medtech Co., Ltd. | 2025-06-25 | Special | PDF ↗ |
| K250866 | Sovereign Posterior Cervical System | Met One Technologies, LLC | 2025-05-20 | Traditional | PDF ↗ |
| K242674 | Freedom Posterior Cervical Screws | Signature Orthopaedics Pty, Ltd. | 2025-05-13 | Traditional | PDF ↗ |
| K250332 | Virage® OCT Spinal Fixation System | Highridge Medical, LLC | 2025-04-04 | Traditional | PDF ↗ |
| K242516 | EUROPA Posterior Cervical Fusion System | MiRus, LLC | 2024-11-19 | Traditional | PDF ↗ |
| K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | 2024-03-27 | Traditional | PDF ↗ |
| K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024-03-14 | Traditional | PDF ↗ |
| K233332 | Statera-C Spinal System | K&J Consulting Corp. | 2023-11-27 | Traditional | PDF ↗ |
| K233078 | Posterior Cervical Spine System | Double Medical Technology, Inc. | 2023-11-22 | Traditional | PDF ↗ |
| K233366 | SYMPHONY OCT System | Medos International SARL | 2023-11-09 | Special | PDF ↗ |
| K232167 | VySpan PCT System | Vy Spine, LLC | 2023-09-27 | Special | PDF ↗ |
| K231654 | NorthStar OCT System | Seaspine, Inc. | 2023-08-03 | Traditional | PDF ↗ |
| K231840 | CastleLoc-S Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2023-07-20 | Special | PDF ↗ |
| K221307 | Edge Upper Cervical System | Spinal Simplicity, LLC | 2023-07-10 | Traditional | PDF ↗ |
| K230614 | Cortium | Ulrich Medical USA | 2023-05-02 | Traditional | PDF ↗ |
| K223852 | VySpan PCT System | Vy Spine, LLC | 2023-02-24 | Special | PDF ↗ |
| K223764 | INFINITY OCT System | Medtronic Sofamor Danek USA, Inc. | 2023-01-11 | Special | PDF ↗ |
| K220658 | COSY Cervicothoracic Occipital Rod-Screw System | Signus Medizintechnik GmbH | 2022-11-18 | Traditional | PDF ↗ |
| K222107 | Black Diamond POCT Spinal System | Osseus Fusion Systems | 2022-11-03 | Traditional | PDF ↗ |
| K221388 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | 2022-09-09 | Traditional | PDF ↗ |
| K213871 | Ennovate Cervical Spinal and Occiput System | Aesculap Implant Systems, LLC | 2022-07-01 | Traditional | PDF ↗ |
| K220570 | M.U.S.T. MINI Posterior Cervical Screws System Extension | Medacta International S.A. | 2022-04-26 | Traditional | PDF ↗ |
| K220810 | Infinity OCT System and PASS OCT Spinal System | Medicrea International | 2022-04-19 | Special | PDF ↗ |
| K213654 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | 2022-02-23 | Traditional | PDF ↗ |
| K213394 | Vy Spine VySpan PCT System | Vy Spine, LLC | 2021-12-10 | Traditional | PDF ↗ |
| K210887 | Altus Spine Sochi OCT Spinal System | Altus Partners, LLC | 2021-08-20 | Traditional | PDF ↗ |
| K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2021-08-18 | Traditional | PDF ↗ |
| K211993 | Z-LINKPC System | Zavation Medical Products, LLC | 2021-08-11 | Traditional | PDF ↗ |
| K211710 | 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 Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System | Orthofix, Inc. | 2021-07-30 | Traditional | PDF ↗ |
| K210449 | Infinity OCT System, PASS OCT® Spinal System | Medtronic | 2021-03-18 | Special | PDF ↗ |
| K203319 | SYMPHONY OCT System | Medos International SARL | 2021-02-05 | Traditional | PDF ↗ |
| K203125 | Invictus OCT Spinal Fixation System | Alphatec Spine, Inc. | 2020-12-18 | Traditional | PDF ↗ |
| K203149 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020-11-16 | Special | PDF ↗ |
| K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2020-10-08 | Special | PDF ↗ |
| K201481 | Centurion POCT System | Orthofix, Inc. | 2020-06-15 | Special | PDF ↗ |
| K200936 | Invictus CT Spinal Fixation System | Alphatec Spine, Inc. | 2020-05-22 | Traditional | PDF ↗ |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | Spineart | 2020-05-01 | Traditional | PDF ↗ |
| K200863 | Tiger® Occipital-Cervical-Thoracic Spinal Fixation System | Corelink, LLC | 2020-04-28 | Special | PDF ↗ |
| K200896 | Solstice CCI | Life Spine, Inc. | 2020-04-28 | Traditional | PDF ↗ |
| K192013 | VERTICALE® Cervical System | Silony Medical GmbH | 2020-04-07 | Traditional | PDF ↗ |
| K192646 | SYMPHONY OCT System | Medos International SARL | 2020-04-02 | Traditional | PDF ↗ |
| K193615 | NorthStar OCT Spinal System | SeaSpine Orthopedics Corporation | 2020-03-25 | Traditional | PDF ↗ |
| K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020-02-10 | Special | PDF ↗ |
| K193129 | Yukon OCT Spinal System | K2m, Inc. | 2020-02-07 | Traditional | PDF ↗ |
| K192014 | SYPMHONY OCT System | Medos International SARL | 2020-01-24 | Traditional | PDF ↗ |
| K192354 | Innovasis Gibralt Spine System | Innovasis, Inc. | 2019-09-24 | Special | PDF ↗ |
| K191553 | NuVaisve® Reline® Cervical System | Nu Vasive, Incorporated | 2019-08-14 | Traditional | PDF ↗ |
| K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System | Medos International SARL | 2019-07-18 | Traditional | PDF ↗ |
| K191185 | Solanas® Posterior OCT Fixation System | Alphatec Spine | 2019-06-03 | Traditional | PDF ↗ |
| K190751 | Connector System | Orthofix, Inc. | 2019-05-22 | Traditional | PDF ↗ |
| K190631 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2019-04-10 | Special | PDF ↗ |
| K190071 | Perla® Posterior Cervico-Thoracic Fixation System | Spineart | 2019-02-25 | Special | PDF ↗ |
| K182837 | M.U.S.T. Mini Extension | Medacta International S.A. | 2019-01-22 | Traditional | PDF ↗ |
| K183383 | ANAX OCT Spinal System | U&I Corporation | 2018-12-12 | Special | PDF ↗ |
| K182182 | YUKON OCT Spinal System | K2m | 2018-11-15 | Traditional | PDF ↗ |
| K182508 | Saxxony Posterior Cervical Thoracic System | Nexxt Spine, LLC | 2018-11-13 | Traditional | PDF ↗ |
| K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System | K2m, Inc. | 2018-10-05 | Traditional | PDF ↗ |
| K181949 | SYMPHONY OCT System | Medos International SARL | 2018-10-04 | Traditional | PDF ↗ |
| K181440 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2018-07-30 | Special | PDF ↗ |
| K181350 | ASTRA-OCT Spine System | Spinecraft, LLC | 2018-07-06 | Traditional | PDF ↗ |
| K180851 | VERTEX Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2018-04-18 | Special | PDF ↗ |
| K172495 | Reform® POCT System | Precision Spine, Inc. | 2018-04-11 | Traditional | PDF ↗ |
| K180198 | NuVasive® VuePoint® II OCT System | Nu Vasive, Incorporated | 2018-03-15 | Traditional | PDF ↗ |
| K173047 | The Solstice OCT System | Life Spine, Inc. | 2018-02-01 | Traditional | PDF ↗ |
| K180025 | Centurion POCT System | Orthofix, Inc. | 2018-01-22 | Special | PDF ↗ |
| K171834 | G Surgical OCT Spinal System | G Surgical, LLC | 2017-12-19 | Traditional | PDF ↗ |
| K172594 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2017-12-15 | Traditional | PDF ↗ |
| K171250 | BRIDALVEIL Occipital Cervical Thoracic System | Astura Medical | 2017-10-02 | Traditional | PDF ↗ |
| K172279 | PMT Posterior Fixation System | Providence Medical Technology, Inc. | 2017-09-20 | Traditional | PDF ↗ |
| K163375 | INFINITY OCT System | Medtronic Sofamor Danek USA, Inc. | 2017-08-21 | Traditional | PDF ↗ |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2017-08-18 | Traditional | PDF ↗ |
| K172194 | Connector System | Orthofix, Inc. | 2017-08-18 | Traditional | PDF ↗ |
| K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017-08-08 | Traditional | PDF ↗ |
| K171369 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2017-08-01 | Traditional | PDF ↗ |
| K170804 | The Solstice OCT System | Life Spine, Inc. | 2017-05-18 | Traditional | PDF ↗ |
| K170647 | Connector System | Orthofix, Inc. | 2017-05-11 | Traditional | PDF ↗ |
| K162266 | The Cranial Fusion System | Life Spine, Inc. | 2017-05-01 | Traditional | PDF ↗ |
| K162575 | Z-LINKPC System | Zavation, LLC | 2017-03-03 | Traditional | PDF ↗ |
| K162639 | Proficient Posterior Cervical Spine System | Spine Wave, Inc. | 2017-02-07 | Traditional | PDF ↗ |
| K161637 | Poseidon OCT Spinal Fixation System | Medyssey USA, Inc. | 2017-01-05 | Traditional | PDF ↗ |
| K161032 | neon3 universal OCT spinal stabilization | Ulrich GmbH & Co. KG | 2016-12-22 | Traditional | PDF ↗ |
| K162300 | Reform® POCT System | Precision Spine, Inc. | 2016-11-22 | Traditional | PDF ↗ |
| K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2016-11-03 | Traditional | PDF ↗ |
| K161591 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016-09-21 | Traditional | PDF ↗ |
| K161478 | Xenco Medical Posterior Cervical System | Xenco Medical, LLC | 2016-09-06 | Traditional | PDF ↗ |
| K161498 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016-08-22 | Traditional | PDF ↗ |
| K153439 | PathLoc-C Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2016-07-21 | Traditional | PDF ↗ |
| K161149 | PASS OCT Spinal System | Medicrea International SA | 2016-07-11 | Traditional | PDF ↗ |
| K160697 | Gibralt® Spine System and Gibralt® Occipital Spine System | Exactech, Inc. | 2016-06-28 | Traditional | PDF ↗ |
| K160428 | Certex Spinal Fixation System | X-Spine Systems, Inc. | 2016-05-05 | Traditional | PDF ↗ |
| K160756 | PASS OCT Spinal System | Medicrea International SA | 2016-04-26 | Traditional | PDF ↗ |
| K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m, Incorporated | 2016-02-16 | Traditional | PDF ↗ |
| K153631 | Zimmer Virage OCT Spinal Fixation System | Zimmer Spine, Inc. | 2016-02-16 | Special | PDF ↗ |
| K153169 | PASS OCT Patient Specific Rods | Medicrea International | 2016-01-29 | Traditional | PDF ↗ |
Product code NKG · Class II · Orthopedic. Data: openFDA.