U2 FEMORAL COMPONENT, CR, POROUS COATED— 510(k) K140075

Name: FDA 510(k) clearance K140075
Creator: U.S. Food and Drug Administration
Published: 2014-06-13

Substantially Equivalent

United Orthopedic Corp.

FDA 510(k) clearance K140075 for U2 FEMORAL COMPONENT, CR, POROUS COATED, Substantially Equivalent on 2014-06-13. Applicant: United Orthopedic Corp.. Device class: 2.

Clearance details

Applicant: United Orthopedic Corp.
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2014-01-13
Decision date: 2014-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

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K122185 — U-MOTION II ACETABULAR SYSTEM2013-02-22
K122183 — AUGMENT AND SCREW, PSA TYPE2013-02-05
K121777 — U2 ACETABULAR CUP, PLASMA SPRAY2012-07-18

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.