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 |
|---|---|---|---|
| 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 |
| K253335 | medtronic sofamor danek usa | CD Horizon Spinal System | October 24, 2025 |
| K252730 | beijing fule science and technology development co | Fule Spinal Fixation System | October 24, 2025 |
| K253249 | medos international sarl | TriALTIS Spine System | October 21, 2025 |
| K252346 | astura medical | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | October 21, 2025 |
| K242827 | allumin8 | A8 INTEGR8 Porous Pedicle Screws | October 20, 2025 |
| K253331 | nexus spine | PressON Spinal Fixation System | October 14, 2025 |
| K252437 | implanet | JAZZ Spinal System | August 28, 2025 |
| K251804 | s.m.a.i.o | KHEIRON® Spinal Fixation System, including patient specific K-ROD | July 8, 2025 |
| K251719 | ulrich medical usa | Momentum® Posterior Spinal Fixation System | July 1, 2025 |
| K250908 | seaspine orthopedics corporation | Virata Spinal Fixation System | June 18, 2025 |
| K251154 | ht medical d.b.a. xenix medical | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instru | June 12, 2025 |