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

    GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)

    K Number: K023087 · Decision Dec 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    288
    Review Days
    90

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    Basic Information

    Device Name
    GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
    K Number
    K023087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp.
    Date Received
    September 17, 2002
    Decision Date
    December 16, 2002
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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    Other Clearances by Howmedica Osteonics Corp.

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    K130895 REUNION RSA SHOULDER SYSTEM
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    K122015 DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
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    K122853 NOVEL FIT AND FILL STEM
    K121315 STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
    K121308 HIP SYSTEMS
    K113409 S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
    Search all 288 clearances from Howmedica Osteonics Corp. →