K233574
- 510(k) number
- K233574
- Device name
- Total Wrist Arthroplasty System (TWA)
- Applicant
- Skeletal Dynamics FL · US
- Product code
- JWJ — Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articu
- Decision date
- 2024-07-03
- Date received
- 2023-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233574.pdf
Official FDA record: K233574
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.