K232303
- 510(k) number
- K232303
- Device name
- ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
- Applicant
- Depuy Ireland UC IE
- Product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constra
- Decision date
- 2023-12-11
- Date received
- 2023-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232303.pdf
Official FDA record: K232303
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.