DEPUY ACE VERSANAIL TIBIAL NAIL— 510(k) K032097

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K032097 for DEPUY ACE VERSANAIL TIBIAL NAIL, Substantially Equivalent on 2003-08-08. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2003-07-08
Decision date: 2003-08-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

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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.