NKG — Posterior Cervical Screw System Class II
FDA product code NKG covers "Posterior Cervical Screw System", a Class II medical device regulated under 21 CFR 888.3075. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253195 | zhejiang decans medical devices co | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | June 2, 2026 |
| K254045 | carbofix orthopedics | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervic | March 16, 2026 |
| 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 |