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

    QUATROLOC FEMORAL COMPONENT & HEAD

    K Number: K961625 · Decision Sep 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    13
    Review Days
    137

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    Basic Information

    Device Name
    QUATROLOC FEMORAL COMPONENT & HEAD
    K Number
    K961625
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Whiteside Biomechanics, Inc.
    Date Received
    April 26, 1996
    Decision Date
    September 10, 1996
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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    Other Clearances by Whiteside Biomechanics, Inc.

    K Number Device Name
    K033313 QUATRO M FEMORAL COMPONENT
    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
    Search all 13 clearances from Whiteside Biomechanics, Inc. →