ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS— 510(k) K041872

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K041872 for ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS, Substantially Equivalent on 2004-09-08. Applicant: Biomet Manufacturing Corp.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2004-07-09
Decision date: 2004-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, 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.