3DKNEE POROUS COATED FEMORAL COMPONENT— 510(k) K032905

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K032905 for 3DKNEE POROUS COATED FEMORAL COMPONENT, Substantially Equivalent on 2004-07-06. Applicant: Encore Orthopedics, Inc..

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2003-09-17
Decision date: 2004-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.