RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD— 510(k) K071053

Name: FDA 510(k) clearance K071053
Creator: U.S. Food and Drug Administration
Published: 2007-06-29

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K071053 for RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD, Substantially Equivalent on 2007-06-29. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KXA
Device class: Class 2
Regulation: 21 CFR 888.3400
Advisory panel: Orthopedic
Date received: 2007-04-13
Decision date: 2007-06-29
Decision: Substantially Equivalent
Clearance type: Special
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.