NKB — Thoracolumbosacral Pedicle Screw System Class II
FDA product code NKB covers "Thoracolumbosacral Pedicle Screw System", a Class II medical device regulated under 21 CFR 888.3070. 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
- 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 |
|---|---|---|---|
| K262091 | ortler global tibbi gerecler anonim sirketi | FRAXION Spinal Fixation System | September 17, 2026 |
| K262193 | xenix medical | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor | September 14, 2026 |
| K262828 | s.m.a.i.o | KHEIRON® Spinal Fixation System, including patient specific K-ROD | September 4, 2026 |
| K253943 | zavation medical products | Tiger 2 System | July 24, 2026 |
| K260362 | mantiz co | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co | July 24, 2026 |
| K261284 | alphatec spine | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy | July 14, 2026 |
| K253802 | s.m.a.i.o | KHEIRON® Spinal Fixation System, including patient specific K-ROD | July 1, 2026 |
| 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 |