SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM— 510(k) K970733

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K970733 for SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM, Substantially Equivalent on 1997-04-02. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1997-02-28
Decision date: 1997-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.