K230563
- 510(k) number
- K230563
- Device name
- EVOLUTION® Hinge Knee System
- Applicant
- Microport Orthopedics, Inc. TN · US
- Product code
- KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemente
- Decision date
- 2023-09-27
- Date received
- 2023-03-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230563.pdf
Official FDA record: K230563
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.