SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM— 510(k) K963325

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K963325 for SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM, Substantially Equivalent on 1997-03-25. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1996-08-23
Decision date: 1997-03-25
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.