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

    ISOBAR SPINAL SYSTEM

    K Number: K013447 · Decision Jan 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    ISOBAR SPINAL SYSTEM
    K Number
    K013447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scien'Tx USA, Inc.
    Date Received
    October 17, 2001
    Decision Date
    January 15, 2002
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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    Other Clearances by Scien'Tx USA, Inc.

    K Number Device Name
    K020245 MODIFICATION TO ISOBAR SPINAL SYSTEM
    K013439 ANTERIOR CERVICAL PLATE SYSTEM
    K013444 ISOBAR SPINAL SYSTEM
    K013440 ISOBAR SPINAL SYSTEM
    K991326 ISOBAR SEMI-RIGID SPINAL SYSTEM
    K990721 ISOLOCK SPINAL SYSTEM
    K990118 ISOBAR SPINAL SYSTEM