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

    ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW

    K Number: K926417 · Decision Sep 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    20
    Review Days
    644

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    Basic Information

    Device Name
    ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
    K Number
    K926417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Mfg., Inc.
    Date Received
    December 23, 1992
    Decision Date
    September 28, 1994
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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    Other Clearances by Alphatec Mfg., Inc.

    K Number Device Name
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    K020356 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
    K993513 DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
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    K992350 PYLON INTRAMEDULLAARY NAIL SYSTEM
    K980788 ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
    K964400 ALPHATEC EXTERNAL FIXATION SYSTEM
    K951846 MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
    K930515 ALPHA SPINAL SYSTEM
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