K241292
- 510(k) number
- K241292
- Device name
- MyShoulder Planner (5.3SSWPL)
- Applicant
- Medacta International S.A. CH
- Product code
- KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polyme
- Decision date
- 2025-01-30
- Date received
- 2024-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K241292.pdf
Official FDA record: K241292
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.