DEPUY ASR RESURFACING FEMORAL HEADS— 510(k) K032659

Name: FDA 510(k) clearance K032659
Creator: U.S. Food and Drug Administration
Published: 2003-12-04

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K032659 for DEPUY ASR RESURFACING FEMORAL HEADS, Substantially Equivalent on 2003-12-04. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code KXA
Device class: Class 2
Regulation: 21 CFR 888.3400
Advisory panel: Orthopedic
Date received: 2003-08-28
Decision date: 2003-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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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.