BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CRADLE FIXATION DEVICE

    K Number: K941772 · Decision Aug 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    7
    Review Days
    483

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    Basic Information

    Device Name
    CRADLE FIXATION DEVICE
    K Number
    K941772
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neoligaments, Ltd.
    Date Received
    April 11, 1994
    Decision Date
    August 7, 1995
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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    K913461 FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM
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