36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT— 510(k) K070061

Name: FDA 510(k) clearance K070061
Creator: U.S. Food and Drug Administration
Published: 2007-01-31

Substantially Equivalent

Hayes Medical, Inc.

FDA 510(k) clearance K070061 for 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT, Substantially Equivalent on 2007-01-31. Applicant: Hayes Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hayes Medical, Inc.
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2007-01-05
Decision date: 2007-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

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K030151 — CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM2003-04-10
K030205 — CONSENSUS UNIPOLAR HEAD, COCR2003-04-01
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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.