K243915
- 510(k) number
- K243915
- Device name
- FIX-C 3D Ti ACIF System
- Applicant
- Jeil Medical Corporation KR
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2025-02-18
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain
Also available from FDA: K243915.pdf
Official FDA record: K243915
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.