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

    BIPOLAR FEMORAL HEAD

    K Number: K981238 · Decision Aug 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    13
    Review Days
    140

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    Basic Information

    Device Name
    BIPOLAR FEMORAL HEAD
    K Number
    K981238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Whiteside Biomechanics, Inc.
    Date Received
    April 3, 1998
    Decision Date
    August 21, 1998
    Product Code
    KWY
    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
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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    Other Clearances by Whiteside Biomechanics, Inc.

    K Number Device Name
    K033313 QUATRO M FEMORAL COMPONENT
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    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
    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. →