BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    U2 FEMORAL COMPONENT, CR, POROUS COATED

    K Number: K140075 · Decision Jun 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    20
    Review Days
    151

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    Basic Information

    Device Name
    U2 FEMORAL COMPONENT, CR, POROUS COATED
    K Number
    K140075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United Orthopedic Corp.
    Date Received
    January 13, 2014
    Decision Date
    June 13, 2014
    Product Code
    MBH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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    Other Clearances by United Orthopedic Corp.

    K Number Device Name
    K140073 U2 FEMORAL COMPONENT, CR, CEMENTED
    K132455 U-MOTION II PS+ CUP
    K122185 U-MOTION II ACETABULAR SYSTEM
    K122183 AUGMENT AND SCREW, PSA TYPE
    K121777 U2 ACETABULAR CUP, PLASMA SPRAY
    K111546 U2 HIP SYSTEM
    K103497 CERAMIC FEMORAL HEAD
    K101670 UNITED U2 BIPOLAR IMPLANT
    K100981 UNITED STEM, PSA TYPE
    K082424 UNITED U2 TOTAL KNEE SYSTEM
    Search all 20 clearances from United Orthopedic Corp. →