OMNI ARC MONOBLOCK HIP STEM— 510(k) K133381

Substantially Equivalent

Omnilife Science

FDA 510(k) clearance K133381 for OMNI ARC MONOBLOCK HIP STEM, Substantially Equivalent on 2014-03-13. Applicant: Omnilife Science.

Clearance details

Applicant: Omnilife Science
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2013-11-04
Decision date: 2014-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Taunton, MA, 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.