K230078
- 510(k) number
- K230078
- Device name
- TRAX® CR Total Knee System
- Applicant
- Amplitude FR
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2023-11-03
- Date received
- 2023-01-10
- 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: K230078.pdf
Official FDA record: K230078
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.