U2 Femoral Component, CR, Porous Coated, Additional Sizes— 510(k) K150832

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K150832 for U2 Femoral Component, CR, Porous Coated, Additional Sizes, Substantially Equivalent on 2015-09-25. Applicant: United Orthopedic Corporation.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2015-03-30
Decision date: 2015-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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.