510(k) K253401 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SCRIPT Implant System
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Apr 29, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253401
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.