ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL— 510(k) K932593

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K932593 for ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL, Substantially Equivalent on 1994-03-10. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 1993-05-28
Decision date: 1994-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.