K230831
- 510(k) number
- K230831
- Device name
- INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
- Applicant
- Depuy Ireland UC IE
- Product code
- MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polyme
- Decision date
- 2023-11-13
- Date received
- 2023-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K230831.pdf
Official FDA record: K230831
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.