E1 ANTIOXIDANT INFUSED TECHNOLOGY— 510(k) K100048

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K100048 for E1 ANTIOXIDANT INFUSED TECHNOLOGY, Substantially Equivalent on 2010-03-09. Applicant: Biomet Manufacturing Corp.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code OIY
Advisory panel: Orthopedic
Date received: 2010-01-08
Decision date: 2010-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code OIY

product code OIY

Injury: 607
Total: 607

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.