APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)— 510(k) K100151

Substantially Equivalent

Omnlife Science

FDA 510(k) clearance K100151 for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM), Substantially Equivalent on 2010-05-28. Applicant: Omnlife Science.

Clearance details

Applicant: Omnlife Science
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2010-01-19
Decision date: 2010-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.