NKG — Posterior Cervical Screw System Class II

FDA Device Classification

Classification Details

Product Code
NKG
Device Class
Class II
Regulation Number
888.3075
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K254165medtronic sofamor danek usaInfinity™ OCT SystemJanuary 21, 2026
K252327icotecCMORE® CT System; CMORE® CT System Navigated InstrumentsNovember 12, 2025
K253129medtronic sofamor danek usaInfinity™ OCT SystemOctober 24, 2025
K251725cg medtech coANAX™ OCT Spinal SystemJune 25, 2025
K250866met one technologiesSovereign Posterior Cervical SystemMay 20, 2025
K242674signature orthopaedics ptyFreedom Posterior Cervical ScrewsMay 13, 2025
K250332highridge medicalVirage® OCT Spinal Fixation SystemApril 4, 2025
K242516mirusEUROPA™ Posterior Cervical Fusion SystemNovember 19, 2024
K233989carbofix orthopedicsCarboClear® Posterior Cervical Screw SystemMarch 27, 2024
K231850globus medicalQUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsMarch 14, 2024
K233332k and j consultingStatera-C™ Spinal SystemNovember 27, 2023
K233078double medical technologyPosterior Cervical Spine SystemNovember 22, 2023
K233366medos international sarlSYMPHONY OCT SystemNovember 9, 2023
K232167vy spineVySpan™ PCT SystemSeptember 27, 2023
K231654seaspineNorthStar OCT SystemAugust 3, 2023
K231840l and k biomed coCastleLoc-S Posterior Cervical Fixation SystemJuly 20, 2023
K221307spinal simplicityEdge Upper Cervical SystemJuly 10, 2023
K230614ulrich medical usaCortium™May 2, 2023
K223852vy spineVySpan™ PCT SystemFebruary 24, 2023
K223764medtronic sofamor danek usaINFINITY OCT SystemJanuary 11, 2023