SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)— 510(k) K092909

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K092909 for SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE), Substantially Equivalent on 2010-01-11. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2009-09-22
Decision date: 2010-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.