K252352
- 510(k) number
- K252352
- Device name
- SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
- Applicant
- Lima Corporate S.P.A. IT
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-01-22
- Date received
- 2025-07-29
- 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: K252352.pdf
Official FDA record: K252352
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.