K253401
- 510(k) number
- K253401
- Device name
- SCRIPT Implant System
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-04-29
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253401.pdf
Official FDA record: K253401
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.