K233712
- 510(k) number
- K233712
- Device name
- PRIMA Humeral System; PRIMA TT Glenoid
- Applicant
- Lima Corporate S.P.A. IT
- Product code
- MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polyme
- Decision date
- 2024-01-11
- Date received
- 2023-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233712.pdf
Official FDA record: K233712
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.