K251431
- 510(k) number
- K251431
- Device name
- FIX-C PEEK ACIF SA System
- Applicant
- Jeil Medical Corporation KR
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-06-27
- Date received
- 2025-05-08
- 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: K251431.pdf
Official FDA record: K251431
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.