SCRIPT Implant System
K-Number: K253401 · 2026-04-29
ApplicantGlobus Medical, Inc.
Decision Date2026-04-29
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SCRIPT Implant System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2026-04-29 under approval number K253401. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SCRIPT Implant System?
SCRIPT Implant System is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by Globus Medical, Inc.. The 510(k) number is K253401.
When was SCRIPT Implant System approved by the FDA?
SCRIPT Implant System received FDA 510(k) clearance on 2026-04-29, under approval number K253401.
What company makes SCRIPT Implant System?
SCRIPT Implant System is manufactured by Globus Medical, Inc..
What is the FDA product code for SCRIPT Implant System?
The FDA product code for SCRIPT Implant System is OVD.
Other Devices by Globus Medical, Inc.
Related Devices (Code: OVD)
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.