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

    MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS

    K Number: K951846 · Decision Feb 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    20
    Review Days
    300

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    Basic Information

    Device Name
    MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
    K Number
    K951846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Alphatec Mfg., Inc.
    Date Received
    April 20, 1995
    Decision Date
    February 14, 1996
    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 Alphatec Mfg., Inc.

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    K992350 PYLON INTRAMEDULLAARY NAIL SYSTEM
    K980788 ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
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