APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD— 510(k) K101451

Substantially Equivalent

Omni Life Science, Inc.

FDA 510(k) clearance K101451 for APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD, Substantially Equivalent on 2010-06-22. Applicant: Omni Life Science, Inc..

Clearance details

Applicant: Omni Life Science, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2010-05-25
Decision date: 2010-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: East Taunton, MA, 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.