K240716
- 510(k) number
- K240716
- Device name
- AETOS Shoulder System Stemless Humeral Prosthesis
- Applicant
- Smith & Nephew, Inc. TN · US
- Product code
- PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Meta
- Decision date
- 2024-11-20
- Date received
- 2024-03-15
- 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: K240716.pdf
Official FDA record: K240716
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.