SMR Reverse HP Shoulder System— 510(k) K243826

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K243826 for SMR Reverse HP Shoulder System, Substantially Equivalent on 2025-07-03. Applicant: Lima Corporate S.P.A..

Clearance details

Applicant: Lima Corporate S.P.A.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2024-12-12
Decision date: 2025-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Udine, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.