DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS— 510(k) K070292

Substantially Equivalent

Zimmer GmbH

FDA 510(k) clearance K070292 for DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS, Substantially Equivalent on 2007-04-26. Applicant: Zimmer GmbH.

Clearance details

Applicant: Zimmer GmbH
Product code: Code KXA
Advisory panel: Orthopedic
Date received: 2007-01-31
Decision date: 2007-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KXA

product code KXA

Injury: 324
Total: 324

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.