Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System

K-Number: K253739 · 2026-05-07

ApplicantGlobus Medical, Inc.
Decision Date2026-05-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2026-05-07 under approval number K253739. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System?

SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System is a medical device that received FDA 510(k) clearance on 2026-05-07. It is manufactured by Globus Medical, Inc.. The 510(k) number is K253739.

When was SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System approved by the FDA?

SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System received FDA 510(k) clearance on 2026-05-07, under approval number K253739.

What company makes SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System?

SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System is manufactured by Globus Medical, Inc..

What is the FDA product code for SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System?

The FDA product code for SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System is NKB.

Other Devices by Globus Medical, Inc.

K253401SCRIPT™ Implant System

Related Devices (Code: NKB)

K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI) K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd. K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑