BEUDAMED
    Product Code: NKG FDA class 2 21 CFR 888.3075

    Posterior Cervical Screw System

    Orthopedic

    The Posterior Cervical Screw System is an orthopedic implant intended for use in fusion procedures of the cervical spine, craniocervical junction, and/or cervicothoracic junction, indicated for spinal fractures and dislocations, deformities, instabilities, failed fusions, tumors, inflammatory disorders, spinal degeneration, facet degeneration with instability, and reconstruction following decompression for radiculopathy or myelopathy. It may also provide temporary stabilization in patients with cervical spine tumors when life expectancy is insufficient for fusion achievement. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NKG and regulation 21 CFR 888.3075 in the Orthopedic specialty. The device is flagged as an implant but is not life-sustaining.

    View on FDA
    510(k)s
    113
    FEI Numbers
    143
    Registration Numbers
    143
    Unique Applicants
    80
    Years Active
    10

    Basic Information

    Product Code
    NKG
    Device Class
    FDA class 2
    Regulation Number
    888.3075
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 113 510(k) clearances via K numbers.

    K Number Device Name
    K251725 ANAX™ OCT Spinal System
    K250866 Sovereign Posterior Cervical System
    K242674 Freedom Posterior Cervical Screws
    K250332 Virage® OCT Spinal Fixation System
    K242516 EUROPA™ Posterior Cervical Fusion System
    K233989 CarboClear® Posterior Cervical Screw System
    K231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
    K233332 Statera-C™ Spinal System
    K233078 Posterior Cervical Spine System
    K233366 SYMPHONY OCT System
    K232167 VySpan™ PCT System
    K231654 NorthStar OCT System
    K231840 CastleLoc-S Posterior Cervical Fixation System
    K221307 Edge Upper Cervical System
    K230614 Cortium™
    K223852 VySpan™ PCT System
    K223764 INFINITY OCT System
    K220658 COSY Cervicothoracic Occipital Rod-Screw System
    K222107 Black Diamond™ POCT Spinal System
    K221388 NuVasive Reline Cervical System
    K213871 Ennovate Cervical Spinal and Occiput System
    K220570 M.U.S.T. MINI Posterior Cervical Screws System Extension
    K220810 Infinity™ OCT System and PASS OCT Spinal System
    K213654 NuVasive Reline Cervical System
    K213394 Vy Spine™ VySpan™ PCT System
    K210887 Altus Spine Sochi OCT Spinal System
    K211957 QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
    K211993 Z-LINKPC System
    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
    K210449 Infinity™ OCT System, PASS OCT® Spinal System
    K203319 SYMPHONY™ OCT System
    K203125 Invictus™ OCT Spinal Fixation System
    K203149 M.U.S.T. MINI Posterior Cervical Screws System
    K200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
    K201481 Centurion POCT System
    K200936 Invictus™ CT Spinal Fixation System
    K200571 PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
    K200896 Solstice CCI
    K200863 Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
    K192013 VERTICALE® Cervical System
    K192646 SYMPHONY™ OCT System
    K193615 NorthStar™ OCT Spinal System
    K200130 M.U.S.T. MINI Posterior Cervical Screws System
    K193129 Yukon OCT Spinal System
    K192014 SYPMHONY™ OCT System
    K192354 Innovasis Gibralt Spine System
    K191553 NuVaisve® Reline® Cervical System
    K190895 MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
    K191185 Solanas® Posterior OCT Fixation System
    K190751 Connector System
    K190631 M.U.S.T. MINI Posterior Cervical Screws System
    K190071 Perla® Posterior Cervico-Thoracic Fixation System
    K182837 M.U.S.T. Mini Extension
    K183383 ANAX™ OCT Spinal System
    K182182 YUKON OCT Spinal System
    K182508 Saxxony™ Posterior Cervical Thoracic System
    K181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
    K181949 SYMPHONY™ OCT System
    K181440 Proficient® Posterior Cervical Spine System
    K181350 ASTRA-OCT Spine System
    K180851 VERTEX™ Reconstruction System
    K172495 Reform® POCT System
    K180198 NuVasive® VuePoint® II OCT System
    K173047 The Solstice OCT System
    K180025 Centurion POCT System
    K171834 G Surgical OCT Spinal System
    K172594 Proficient® Posterior Cervical Spine System
    K171250 BRIDALVEIL Occipital Cervical Thoracic System
    K172279 PMT Posterior Fixation System
    K163375 INFINITY™ OCT System
    K172194 Connector System
    K172139 Streamline OCT Occipito-Cervico-Thoracic System
    K171444 YUKON OCT Spinal System
    K171369 M.U.S.T. MINI Posterior Cervical Screws System
    K170804 The Solstice OCT System
    K170647 Connector System
    K162266 The Cranial Fusion System
    K162575 Z-LINKPC System
    K162639 Proficient™ Posterior Cervical Spine System
    K161637 Poseidon OCT Spinal Fixation System
    K161032 neon3™ universal OCT spinal stabilization
    K162300 Reform® POCT System
    K162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System
    K161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
    K161478 Xenco Medical Posterior Cervical System
    K161498 Streamline OCT Occipito-Cervico-Thoracic System
    K153439 PathLoc-C Posterior Cervical Fixation System
    K161149 PASS OCT Spinal System
    K160697 Gibralt® Spine System and Gibralt® Occipital Spine System
    K160428 Certex Spinal Fixation System
    K160756 PASS OCT Spinal System
    K153631 Zimmer Virage OCT Spinal Fixation System
    K153370 Caspian OCT/MESA Mini/DENALI Mini Spinal System
    K153169 PASS OCT Patient Specific Rods
    K153386 Perla Posterior Cervico-Thoracic Fixation system
    K153336 VuePoint OCT System
    K152211 PCT System
    K152338 VERTEX(r) Reconstruction System
    K151938 S4 Cervical Spinal and Occiput Systems
    K150474 NuVasive VuePoint II OCT System
    K150918 PASS OCT Spinal System
    K150650 neon3
    K151885 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System
    K151705 Lotus Posterior Cervical/Thoracic Spinal System
    K151755 OASYS(r) System
    K151224 Lineum OCT Spine System
    K151031 Virage OCT Spinal Fixation System
    K150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
    K150570 ANAX OCT Spinal System
    K150822 Centurion POCT System
    K150539 OASYS System
    K143471 VERTEX Reconstruction System
    K142838 Synapse Occipital-Cervical-Thoracic (OCT) System

    FEI Numbers

    This FDA classification entry is associated with 143 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 143 registration numbers. Click on an entry to view related FDA registrations.