Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NKG — Predicate Candidate Screening
118 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
236 days90th percentile
118clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-02 | 249 | 0 |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hyb | CarboFix Orthopedics , Ltd. | 2026-03-16 | 89 | 0 |
| K254165 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2026-01-21 | 30 | 0 |
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025-11-12 | 110 | 0 |
| K253129 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 | 29 | 0 |
| K251725 | ANAX™ OCT Spinal System | Cg Medtech Co., Ltd. | 2025-06-25 | 20 | 0 |
| K250866 | Sovereign Posterior Cervical System | Met One Technologies, LLC | 2025-05-20 | 57 | 0 |
| K242674 | Freedom Posterior Cervical Screws | Signature Orthopaedics Pty, Ltd. | 2025-05-13 | 249 | 0 |
| K250332 | Virage® OCT Spinal Fixation System | Highridge Medical, LLC | 2025-04-04 | 58 | 0 |
| K242516 | EUROPA™ Posterior Cervical Fusion System | MiRus, LLC | 2024-11-19 | 88 | 0 |
| K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. | 2024-03-27 | 100 | 0 |
| K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGP | Globus Medical, Inc. | 2024-03-14 | 265 | 0 |
| K233332 | Statera-C™ Spinal System | K&J Consulting Corp. | 2023-11-27 | 59 | 0 |
| K233078 | Posterior Cervical Spine System | Double Medical Technology, Inc. | 2023-11-22 | 58 | 0 |
| K233366 | SYMPHONY OCT System | Medos International SARL | 2023-11-09 | 38 | 0 |
| K232167 | VySpan™ PCT System | Vy Spine, LLC | 2023-09-27 | 68 | 0 |
| K231654 | NorthStar OCT System | Seaspine, Inc. | 2023-08-03 | 58 | 0 |
| K231840 | CastleLoc-S Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2023-07-20 | 28 | 0 |
| K221307 | Edge Upper Cervical System | Spinal Simplicity, LLC | 2023-07-10 | 431 | 0 |
| K230614 | Cortium™ | Ulrich Medical USA | 2023-05-02 | 57 | 0 |
| K223852 | VySpan™ PCT System | Vy Spine, LLC | 2023-02-24 | 64 | 0 |
| K223764 | INFINITY OCT System | Medtronic Sofamor Danek USA, Inc. | 2023-01-11 | 27 | 0 |
| K220658 | COSY Cervicothoracic Occipital Rod-Screw System | Signus Medizintechnik GmbH | 2022-11-18 | 256 | 0 |
| K222107 | Black Diamond™ POCT Spinal System | Osseus Fusion Systems | 2022-11-03 | 108 | 0 |
| K221388 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | 2022-09-09 | 119 | 0 |
| K213871 | Ennovate Cervical Spinal and Occiput System | Aesculap Implant Systems, LLC | 2022-07-01 | 200 | 0 |
| K220570 | M.U.S.T. MINI Posterior Cervical Screws System Extension | Medacta International S.A. | 2022-04-26 | 57 | 0 |
| K220810 | Infinity™ OCT System and PASS OCT Spinal System | Medicrea International | 2022-04-19 | 29 | 0 |
| K213654 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | 2022-02-23 | 96 | 0 |
| K213394 | Vy Spine™ VySpan™ PCT System | Vy Spine, LLC | 2021-12-10 | 56 | 0 |
| K210887 | Altus Spine Sochi OCT Spinal System | Altus Partners, LLC | 2021-08-20 | 148 | 0 |
| K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navi | Globus Medical, Inc. | 2021-08-18 | 55 | 0 |
| K211993 | Z-LINKPC System | Zavation Medical Products, LLC | 2021-08-11 | 44 | 0 |
| K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation S | Orthofix, Inc. | 2021-07-30 | 57 | 0 |
| K210449 | Infinity™ OCT System, PASS OCT® Spinal System | Medtronic | 2021-03-18 | 30 | 0 |
| K203319 | SYMPHONY™ OCT System | Medos International SARL | 2021-02-05 | 85 | 0 |
| K203125 | Invictus™ OCT Spinal Fixation System | Alphatec Spine, Inc. | 2020-12-18 | 60 | 0 |
| K203149 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020-11-16 | 25 | 0 |
| K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Poste | L&K BIOMED Co., Ltd. | 2020-10-08 | 196 | 0 |
| K201481 | Centurion POCT System | Orthofix, Inc. | 2020-06-15 | 11 | 0 |
| K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020-05-22 | 44 | 0 |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | Spineart | 2020-05-01 | 58 | 0 |
| K200896 | Solstice CCI | Life Spine, Inc. | 2020-04-28 | 25 | 0 |
| K200863 | Tiger® Occipital-Cervical-Thoracic Spinal Fixation System | Corelink, LLC | 2020-04-28 | 27 | 0 |
| K192013 | VERTICALE® Cervical System | Silony Medical GmbH | 2020-04-07 | 253 | 0 |
| K192646 | SYMPHONY™ OCT System | Medos International SARL | 2020-04-02 | 191 | 0 |
| K193615 | NorthStar™ OCT Spinal System | SeaSpine Orthopedics Corporation | 2020-03-25 | 90 | 0 |
| K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020-02-10 | 20 | 0 |
| K193129 | Yukon OCT Spinal System | K2m, Inc. | 2020-02-07 | 87 | 0 |
| K192014 | SYPMHONY™ OCT System | Medos International SARL | 2020-01-24 | 179 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda