K233260
- 510(k) number
- K233260
- Device name
- Univers Revers CA Head and Adapter
- Applicant
- Arthrex, Inc. FL · US
- Product code
- HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncem
- Decision date
- 2024-02-12
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K233260.pdf
Official FDA record: K233260
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.