SCRIPT Implant System— 510(k) K253401
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K253401 for SCRIPT Implant System, Substantially Equivalent on 2026-04-29. Applicant: Globus Medical, Inc.. Device class: 2.
Summary
Globus Medical's SCRIPT Implant System is filed under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3080. It came in as a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
Globus Medical filed from Audubon, Pennsylvania. Review took 211 calendar days (September 30, 2025 to April 29, 2026).
Clearance details
- Applicant
- Globus Medical, Inc.
- Product code
- Product code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Audubon, PA, US
Recent devices under product code OVD
view allMore clearances from Globus Medical, Inc.
view all- K262779 — ANTHEM Fracture System
- K254043 — TRIVANCE Hip Stem
- K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)
- K253739 — SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
- K261043 — AUTOBAHN Nailing System
Adverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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.