K252416
- 510(k) number
- K252416
- Device name
- AETOS Shoulder System Meta Humeral Prosthesis Size 0
- Applicant
- Smith & Nephew, Inc. TN · US
- Product code
- KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polyme
- Decision date
- 2025-10-29
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252416.pdf
Official FDA record: K252416
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.