K243973
- 510(k) number
- K243973
- Device name
- FIX-L PEEK PLIF and T-PLIF System
- Applicant
- Jeil Medical Corporation KR
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-06-12
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K243973.pdf
Official FDA record: K243973
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.