K240324
- 510(k) number
- K240324
- Device name
- EMPOWR Revision Symmetric Knee Cones
- Applicant
- Encore Medical, L.P. (Dba Enovis) TX · US
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2024-04-26
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K240324.pdf
Official FDA record: K240324
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.