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

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..

Clearance details

Applicant: Hayes Medical, Inc.
Product code: Code LWJ
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

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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.