K241570
- 510(k) number
- K241570
- Device name
- Unity Total Knee System
- Applicant
- Corin U.S.A. Limited FL · US
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2024-09-23
- Date received
- 2024-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K241570.pdf
Official FDA record: K241570
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.