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

    COLLES FRACTURE FRAME

    K Number: K830154 · Decision Feb 2, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    48
    Review Days
    15

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    Basic Information

    Device Name
    COLLES FRACTURE FRAME
    K Number
    K830154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    January 18, 1983
    Decision Date
    February 2, 1983
    Product Code
    JEC
    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
    JEC Component, Traction, Invasive

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

    K Number Device Name
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    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
    K823725 SPECTRON PROTRUSIO CUP
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