BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    QUATRO M FEMORAL COMPONENT

    K Number: K033313 · Decision Jul 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    80
    Applicant Total
    13
    Review Days
    287

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    Basic Information

    Device Name
    QUATRO M FEMORAL COMPONENT
    K Number
    K033313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Whiteside Biomechanics, Inc.
    Date Received
    October 15, 2003
    Decision Date
    July 28, 2004
    Product Code
    LWJ
    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
    LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

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    Other Clearances by Whiteside Biomechanics, Inc.

    K Number Device Name
    K012800 SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
    K003618 WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014
    K993903 WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
    K991678 WHITESIDE BIOMECHANICS SPINAL SYSTEM
    K981238 BIPOLAR FEMORAL HEAD
    K973261 WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
    K964616 QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT
    K971721 WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD
    K971718 MICRO-SEAL ACETABULAR SYSTEM
    K964150 WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
    Search all 13 clearances from Whiteside Biomechanics, Inc. →