K243381
- 510(k) number
- K243381
- Device name
- Total Wrist Arthroplasty System (TWA)
- Applicant
- Skeletal Dynamics, Inc. FL · US
- Product code
- JWJ — Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articu
- Decision date
- 2024-11-01
- Date received
- 2024-10-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243381.pdf
Official FDA record: K243381
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.