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

    ALPHATEC WIRE EXTERNAL FIXATION SYSTEM

    K Number: K980788 · Decision May 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    93
    Applicant Total
    20
    Review Days
    81

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    Basic Information

    Device Name
    ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
    K Number
    K980788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alphatec Mfg., Inc.
    Date Received
    March 2, 1998
    Decision Date
    May 22, 1998
    Product Code
    JDW
    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
    JDW Pin, Fixation, Threaded

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