BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS— 510(k) K090299

Substantially Equivalent

Aesculap Implant Systems

FDA 510(k) clearance K090299 for BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS, Substantially Equivalent on 2009-04-24. Applicant: Aesculap Implant Systems.

Clearance details

Applicant: Aesculap Implant Systems
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2009-02-06
Decision date: 2009-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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.