SYNTHES LCP PROXIMAL TIBIA PLATE— 510(k) K011978

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K011978 for SYNTHES LCP PROXIMAL TIBIA PLATE, Substantially Equivalent on 2001-08-09. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2001-06-25
Decision date: 2001-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.