AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM— 510(k) K962002

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K962002 for AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM, Substantially Equivalent on 1996-08-08. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1996-05-22
Decision date: 1996-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.