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

    ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM

    K Number: K023299 · Decision Dec 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    20
    Review Days
    69

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    Basic Information

    Device Name
    ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
    K Number
    K023299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Mfg., Inc.
    Date Received
    October 3, 2002
    Decision Date
    December 11, 2002
    Product Code
    MNI
    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
    MNI Orthosis, Spinal Pedicle Fixation

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    Other Clearances by Alphatec Mfg., Inc.

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    K993873 ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
    K992350 PYLON INTRAMEDULLAARY NAIL SYSTEM
    K980788 ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
    K964400 ALPHATEC EXTERNAL FIXATION SYSTEM
    K951846 MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
    K926417 ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
    K930515 ALPHA SPINAL SYSTEM
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