LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,— 510(k) K100858

Substantially Equivalent

Lima-Lto S.P.A.

FDA 510(k) clearance K100858 for LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,, Substantially Equivalent on 2010-12-10. Applicant: Lima-Lto S.P.A..

Clearance details

Applicant: Lima-Lto S.P.A.
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2010-03-26
Decision date: 2010-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winona Lake, IN, US

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Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.