K230513
- 510(k) number
- K230513
- Device name
- Arthrex Univers Apex OptiFit Humeral Stem
- Applicant
- Arthrex, Inc. FL · US
- Product code
- KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polyme
- Decision date
- 2023-09-26
- Date received
- 2023-02-24
- 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: K230513.pdf
Official FDA record: K230513
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.