K250076
- 510(k) number
- K250076
- Device name
- Endeavor Stand-Alone Cervical IBF System
- Applicant
- Innovasis UT · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-09-25
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250076.pdf
Official FDA record: K250076
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.