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

    BIOPHASE IMPLANT MATERIAL

    K Number: K792329 · Decision Jan 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    48
    Review Days
    65

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    Basic Information

    Device Name
    BIOPHASE IMPLANT MATERIAL
    K Number
    K792329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    November 19, 1979
    Decision Date
    January 23, 1980
    Product Code
    JDG
    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
    JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

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    Other Clearances by Richard'S Medical Equip., Inc.

    K Number Device Name
    K830793 PATIENT GUIDED ELBOW & SHOULDER EXERC
    K823837 RMC TOTAL KNEE SYSTEM
    K823726 SPECTRON CONVERSION ENDOPROSTHESIS CUP
    K823724 SPECTRON NECK REPLACEMENT PROSTHESIS
    K823723 SPECTRON PROXIMAL FEMORAL PROSTHESIS
    K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
    K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES
    K830153 RICHARDS INTRA-ARTICULAR SHAVER BLADES
    K830154 COLLES FRACTURE FRAME
    K823725 SPECTRON PROTRUSIO CUP
    Search all 48 clearances from Richard'S Medical Equip., Inc. →