NKG — Posterior Cervical Screw System Class II
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254165 | medtronic sofamor danek usa | Infinity OCT System | January 21, 2026 |
| K252327 | icotec | CMORE® CT System; CMORE® CT System Navigated Instruments | November 12, 2025 |
| K253129 | medtronic sofamor danek usa | Infinity OCT System | October 24, 2025 |
| K251725 | cg medtech co | ANAX OCT Spinal System | June 25, 2025 |
| K250866 | met one technologies | Sovereign Posterior Cervical System | May 20, 2025 |
| K242674 | signature orthopaedics pty | Freedom Posterior Cervical Screws | May 13, 2025 |
| K250332 | highridge medical | Virage® OCT Spinal Fixation System | April 4, 2025 |
| K242516 | mirus | EUROPA Posterior Cervical Fusion System | November 19, 2024 |
| K233989 | carbofix orthopedics | CarboClear® Posterior Cervical Screw System | March 27, 2024 |
| K231850 | globus medical | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | March 14, 2024 |
| K233332 | k and j consulting | Statera-C Spinal System | November 27, 2023 |
| K233078 | double medical technology | Posterior Cervical Spine System | November 22, 2023 |
| K233366 | medos international sarl | SYMPHONY OCT System | November 9, 2023 |
| K232167 | vy spine | VySpan PCT System | September 27, 2023 |
| K231654 | seaspine | NorthStar OCT System | August 3, 2023 |
| K231840 | l and k biomed co | CastleLoc-S Posterior Cervical Fixation System | July 20, 2023 |
| K221307 | spinal simplicity | Edge Upper Cervical System | July 10, 2023 |
| K230614 | ulrich medical usa | Cortium | May 2, 2023 |
| K223852 | vy spine | VySpan PCT System | February 24, 2023 |
| K223764 | medtronic sofamor danek usa | INFINITY OCT System | January 11, 2023 |