APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]— 510(k) K080842

Substantially Equivalent

Omni Life Science, Inc.

FDA 510(k) clearance K080842 for APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES], Substantially Equivalent on 2008-05-23. Applicant: Omni Life Science, Inc..

Clearance details

Applicant: Omni Life Science, Inc.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2008-03-25
Decision date: 2008-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.