CEMENTED FEMORAL HEAD RESURFING DEVICE— 510(k) K021799

Name: FDA 510(k) clearance K021799
Creator: U.S. Food and Drug Administration
Published: 2002-06-26

Substantially Equivalent

Biomet Orthopedics, Inc.

FDA 510(k) clearance K021799 for CEMENTED FEMORAL HEAD RESURFING DEVICE, Substantially Equivalent on 2002-06-26. Applicant: Biomet Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Biomet Orthopedics, Inc.
Product code: Code KXA
Device class: Class 2
Regulation: 21 CFR 888.3400
Advisory panel: Orthopedic
Date received: 2002-05-31
Decision date: 2002-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD2007-06-29
K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS2007-04-26

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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.