K253739
- 510(k) number
- K253739
- Device name
- SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-05-07
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K253739.pdf
Official FDA record: K253739
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.