TITANIUM CANNULATED TIBIAL NAIL (TI CTN)— 510(k) K962047

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K962047 for TITANIUM CANNULATED TIBIAL NAIL (TI CTN), Substantially Equivalent on 1996-07-24. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 1996-05-28
Decision date: 1996-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code JDS

product code JDS

Injury: 1,776
Malfunction: 1,509
Total: 3,285

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.