K082468

Substantially Equivalent

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)

Applicant: Omni Life Science, Inc.
Product code: KWY
Advisory panel: Orthopedic
Date received: 2008-08-27
Decision date: 2009-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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.