SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System— 510(k) K253739
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K253739 for SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System, Substantially Equivalent on 2026-05-07. Applicant: Globus Medical, Inc.. Device class: 2.
Summary
Globus Medical's record lists five items: SCRIPT Rods, the CREO Stabilization System, the REVERE Stabilization System, the REVERE 4.5 Stabilization System, and the NuVasive Reline System. The product code is NKB, thoracolumbosacral pedicle screw systems.
Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).
Globus filed from Audubon, Pennsylvania. The decision came 164 calendar days after receipt (November 24, 2025 to May 7, 2026).
Clearance details
- Applicant
- Globus Medical, Inc.
- Product code
- Product code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Audubon, PA, US
Recent devices under product code NKB
view allMore clearances from Globus Medical, Inc.
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.