BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES— 510(k) K073567

Substantially Equivalent

Zimmer GmbH

FDA 510(k) clearance K073567 for BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES, Substantially Equivalent on 2008-03-13. Applicant: Zimmer GmbH.

Clearance details

Applicant: Zimmer GmbH
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2007-12-20
Decision date: 2008-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.