APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)— 510(k) K082468

Name: FDA 510(k) clearance K082468
Creator: U.S. Food and Drug Administration
Published: 2009-02-18

Substantially Equivalent

Omni Life Science, Inc.

FDA 510(k) clearance K082468 for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60), Substantially Equivalent on 2009-02-18. Applicant: Omni Life Science, Inc.. Device class: 2.

Clearance details

Applicant: Omni Life Science, Inc.
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
Advisory panel: Orthopedic
Date received: 2008-08-27
Decision date: 2009-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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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.