K251829
- 510(k) number
- K251829
- Device name
- DeGen Medical Patient Specific Implant (PSI) System
- Applicant
- Degen Medical SC · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-12-08
- Date received
- 2025-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K251829.pdf
Official FDA record: K251829
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.