K253876
- 510(k) number
- K253876
- Device name
- HEDRON Cervical Spacers (HEDRON C-MIS Spacer)
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-12-22
- Date received
- 2025-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253876.pdf
Official FDA record: K253876
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.