Atlas FDA

NKG

118 FDA 510(k) clearances · Product code

71 daysmedian time to decision
236 days90th percentile
118clearances measured

FDA profile

Official device name
Posterior Cervical Screw System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3075
Medical specialty
Orthopedic
Flags
Implant
FDA definition
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Adverse events (MAUDE)
2021: 704 · 2022: 175 · 2023: 131 · 2024: 206 · 2025: 157 · 2026: 64
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (K253195)ZheJiang Decans Medical Devices Co., Ltd.2026-06-02
CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (K254045)CarboFix Orthopedics , Ltd.2026-03-16
Infinity™ OCT System (K254165)Medtronic Sofamor Danek USA, Inc.2026-01-21
CMORE® CT System; CMORE® CT System Navigated Instruments (K252327)Icotec AG2025-11-12
Infinity™ OCT System (K253129)Medtronic Sofamor Danek USA, Inc.2025-10-24
ANAX™ OCT Spinal System (K251725)Cg Medtech Co., Ltd.2025-06-25
Sovereign Posterior Cervical System (K250866)Met One Technologies, LLC2025-05-20
Freedom Posterior Cervical Screws (K242674)Signature Orthopaedics Pty, Ltd.2025-05-13
Virage® OCT Spinal Fixation System (K250332)Highridge Medical, LLC2025-04-04
EUROPA™ Posterior Cervical Fusion System (K242516)MiRus, LLC2024-11-19
CarboClear® Posterior Cervical Screw System (K233989)CarboFix Orthopedics , Ltd.2024-03-27
QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments (K231850)Globus Medical, Inc.2024-03-14
Statera-C™ Spinal System (K233332)K&J Consulting Corp.2023-11-27
Posterior Cervical Spine System (K233078)Double Medical Technology, Inc.2023-11-22
SYMPHONY OCT System (K233366)Medos International SARL2023-11-09
VySpan™ PCT System (K232167)Vy Spine, LLC2023-09-27
NorthStar OCT System (K231654)Seaspine, Inc.2023-08-03
CastleLoc-S Posterior Cervical Fixation System (K231840)L&K BIOMED Co., Ltd.2023-07-20
Edge Upper Cervical System (K221307)Spinal Simplicity, LLC2023-07-10
Cortium™ (K230614)Ulrich Medical USA2023-05-02
VySpan™ PCT System (K223852)Vy Spine, LLC2023-02-24
INFINITY OCT System (K223764)Medtronic Sofamor Danek USA, Inc.2023-01-11
COSY Cervicothoracic Occipital Rod-Screw System (K220658)Signus Medizintechnik GmbH2022-11-18
Black Diamond™ POCT Spinal System (K222107)Osseus Fusion Systems2022-11-03
NuVasive Reline Cervical System (K221388)Nu Vasive, Incorporated2022-09-09
Ennovate Cervical Spinal and Occiput System (K213871)Aesculap Implant Systems, LLC2022-07-01
M.U.S.T. MINI Posterior Cervical Screws System Extension (K220570)Medacta International S.A.2022-04-26
Infinity™ OCT System and PASS OCT Spinal System (K220810)Medicrea International2022-04-19
NuVasive Reline Cervical System (K213654)Nu Vasive, Incorporated2022-02-23
Vy Spine™ VySpan™ PCT System (K213394)Vy Spine, LLC2021-12-10
Altus Spine Sochi OCT Spinal System (K210887)Altus Partners, LLC2021-08-20
QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (K211957)Globus Medical, Inc.2021-08-18
Z-LINKPC System (K211993)Zavation Medical Products, LLC2021-08-11
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 (K211710)Orthofix, Inc.2021-07-30
Infinity™ OCT System, PASS OCT® Spinal System (K210449)Medtronic2021-03-18
SYMPHONY™ OCT System (K203319)Medos International SARL2021-02-05
Invictus™ OCT Spinal Fixation System (K203125)Alphatec Spine, Inc.2020-12-18
M.U.S.T. MINI Posterior Cervical Screws System (K203149)Medacta International S.A.2020-11-16
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System (K200793)L&K BIOMED Co., Ltd.2020-10-08
Centurion POCT System (K201481)Orthofix, Inc.2020-06-15
Invictus™ CT Spinal Fixation System (K200936)Alphatec Spine, Inc.2020-05-22
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System (K200571)Spineart2020-05-01
Solstice CCI (K200896)Life Spine, Inc.2020-04-28
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System (K200863)Corelink, LLC2020-04-28
VERTICALE® Cervical System (K192013)Silony Medical GmbH2020-04-07
SYMPHONY™ OCT System (K192646)Medos International SARL2020-04-02
NorthStar™ OCT Spinal System (K193615)SeaSpine Orthopedics Corporation2020-03-25
M.U.S.T. MINI Posterior Cervical Screws System (K200130)Medacta International S.A.2020-02-10
Yukon OCT Spinal System (K193129)K2m, Inc.2020-02-07
SYPMHONY™ OCT System (K192014)Medos International SARL2020-01-24
Innovasis Gibralt Spine System (K192354)Innovasis, Inc.2019-09-24
NuVaisve® Reline® Cervical System (K191553)Nu Vasive, Incorporated2019-08-14
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System (K190895)Medos International SARL2019-07-18
Solanas® Posterior OCT Fixation System (K191185)Alphatec Spine2019-06-03
Connector System (K190751)Orthofix, Inc.2019-05-22
M.U.S.T. MINI Posterior Cervical Screws System (K190631)Medacta International S.A.2019-04-10
Perla® Posterior Cervico-Thoracic Fixation System (K190071)Spineart2019-02-25
M.U.S.T. Mini Extension (K182837)Medacta International S.A.2019-01-22
ANAX™ OCT Spinal System (K183383)U&I Corporation2018-12-12
YUKON OCT Spinal System (K182182)K2m2018-11-15
Saxxony™ Posterior Cervical Thoracic System (K182508)Nexxt Spine, LLC2018-11-13
EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (K181603)K2m, Inc.2018-10-05
SYMPHONY™ OCT System (K181949)Medos International SARL2018-10-04
Proficient® Posterior Cervical Spine System (K181440)Spine Wave, Inc.2018-07-30
ASTRA-OCT Spine System (K181350)Spinecraft, LLC2018-07-06
VERTEX™ Reconstruction System (K180851)Medtronic Sofamor Danek USA, Inc.2018-04-18
Reform® POCT System (K172495)Precision Spine, Inc.2018-04-11
NuVasive® VuePoint® II OCT System (K180198)Nu Vasive, Incorporated2018-03-15
The Solstice OCT System (K173047)Life Spine, Inc.2018-02-01
Centurion POCT System (K180025)Orthofix, Inc.2018-01-22
G Surgical OCT Spinal System (K171834)G Surgical, LLC2017-12-19
Proficient® Posterior Cervical Spine System (K172594)Spine Wave, Inc.2017-12-15
BRIDALVEIL Occipital Cervical Thoracic System (K171250)Astura Medical2017-10-02
PMT Posterior Fixation System (K172279)Providence Medical Technology, Inc.2017-09-20
INFINITY™ OCT System (K163375)Medtronic Sofamor Danek USA, Inc.2017-08-21
Streamline OCT Occipito-Cervico-Thoracic System (K172139)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2017-08-18
Connector System (K172194)Orthofix, Inc.2017-08-18
YUKON OCT Spinal System (K171444)K2m, Inc.2017-08-08
M.U.S.T. MINI Posterior Cervical Screws System (K171369)Medacta International S.A.2017-08-01
The Solstice OCT System (K170804)Life Spine, Inc.2017-05-18
Connector System (K170647)Orthofix, Inc.2017-05-11
The Cranial Fusion System (K162266)Life Spine, Inc.2017-05-01
Z-LINKPC System (K162575)Zavation, LLC2017-03-03
Proficient™ Posterior Cervical Spine System (K162639)Spine Wave, Inc.2017-02-07
Poseidon OCT Spinal Fixation System (K161637)Medyssey USA, Inc.2017-01-05
neon3™ universal OCT spinal stabilization (K161032)Ulrich GmbH & Co. KG2016-12-22
Reform® POCT System (K162300)Precision Spine, Inc.2016-11-22
CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System (K162136)L&K BIOMED Co., Ltd.2016-11-03
QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (K161591)Globus Medical, Inc.2016-09-21
Xenco Medical Posterior Cervical System (K161478)Xenco Medical, LLC2016-09-06
Streamline OCT Occipito-Cervico-Thoracic System (K161498)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2016-08-22
PathLoc-C Posterior Cervical Fixation System (K153439)L&K BIOMED Co., Ltd.2016-07-21
PASS OCT Spinal System (K161149)Medicrea International SA2016-07-11
Gibralt® Spine System and Gibralt® Occipital Spine System (K160697)Exactech, Inc.2016-06-28
Certex Spinal Fixation System (K160428)X-Spine Systems, Inc.2016-05-05
PASS OCT Spinal System (K160756)Medicrea International SA2016-04-26
Caspian OCT/MESA Mini/DENALI Mini Spinal System (K153370)K2m, Incorporated2016-02-16
Zimmer Virage OCT Spinal Fixation System (K153631)Zimmer Spine, Inc.2016-02-16
PASS OCT Patient Specific Rods (K153169)Medicrea International2016-01-29
Perla Posterior Cervico-Thoracic Fixation system (K153386)Spineart2016-01-25
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