K233980
- 510(k) number
- K233980
- Device name
- ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
- Applicant
- Depuy Ireland UC IE
- Product code
- KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemente
- Decision date
- 2024-03-21
- Date received
- 2023-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K233980.pdf
Official FDA record: K233980
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.