K240678
- 510(k) number
- K240678
- 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
- 2024-06-18
- Date received
- 2024-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K240678.pdf
Official FDA record: K240678
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.