NKB — Thoracolumbosacral Pedicle Screw System Class II
Classification Details
- Product Code
- NKB
- Device Class
- Class II
- Regulation Number
- 888.3070
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253045 | socko medical co | Socko Vimax Spinal Fixation System | June 17, 2026 |
| K251251 | chanpin medtak co | ChanPin Pedicle Screw Spinal System | June 9, 2026 |
| K260989 | kyocera medical technologies inc. (kmti) | Varion Thoracolumbar Fixation System | May 15, 2026 |
| K253739 | globus medical | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® | May 7, 2026 |
| K261130 | l and k biomed co | AccelFix Spinal Fixation System | May 5, 2026 |
| K253966 | spineart | PERLA® TL Posterior Thoraco-lumbar Fixation System | May 1, 2026 |
| K252542 | zhejiang decans medical devices co | LEO Spinal System | April 29, 2026 |
| K253940 | medacta international | M.U.S.T. Pedicle Screw System - Extension | April 28, 2026 |
| K260216 | medtronic sofamor danek usa | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | April 21, 2026 |
| K254274 | life spine | ARx® SAI Implant System | April 16, 2026 |
| K260786 | s.m.a.i.o | KHEIRON® Spinal Fixation System, including patient specific K-ROD | April 3, 2026 |
| K254247 | osteomni | OSTEOMNI SPINAL FIXATION SYSTEM | February 24, 2026 |
| K253169 | box spine | Duet Spinal Fixation System | February 23, 2026 |
| K253545 | k2m | Vulcan Spinal System | February 10, 2026 |
| K252461 | spinal resources | Swedge Pedicle Screw Fixation System Bezier Rod | January 13, 2026 |
| K253990 | s.m.a.i.o | KHEIRON® Spinal Fixation System, including patient specific K-ROD | January 7, 2026 |
| K253941 | medtronic sofamor danek usa | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | January 7, 2026 |
| K253093 | highridge medical | Vital Spinal Fixation System | December 17, 2025 |
| K253721 | s.m.a.i.o | KHEIRON® Spinal Fixation System, including patient specific K-ROD | December 17, 2025 |
| K252729 | double medical technology | Universal Spinal System | November 18, 2025 |