K250667
- 510(k) number
- K250667
- Device name
- DeGen Medical Patient Specific Implant (PSI) System
- Applicant
- Degen Medical SC · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-04-04
- Date received
- 2025-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250667.pdf
Official FDA record: K250667
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.