K240683
- 510(k) number
- K240683
- Device name
- Rx Knee System
- Applicant
- Signature Orthopaedics Pty, Ltd. AU
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2024-09-11
- Date received
- 2024-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240683.pdf
Official FDA record: K240683
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.