SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS— 510(k) K112900

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K112900 for SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS, Substantially Equivalent on 2012-06-01. Applicant: Lima Corporate S.P.A..

Clearance details

Applicant: Lima Corporate S.P.A.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2011-10-03
Decision date: 2012-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winona Lake, IN, US

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Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.