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

    SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM

    K Number: K012800 · Decision May 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    13
    Review Days
    255

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    Basic Information

    Device Name
    SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
    K Number
    K012800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Whiteside Biomechanics, Inc.
    Date Received
    August 21, 2001
    Decision Date
    May 3, 2002
    Product Code
    HRY
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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    Other Clearances by Whiteside Biomechanics, Inc.

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    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
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    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. →