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

    EMERGE MEDICAL IM NAIL SYSTEM

    K Number: K141347 · Decision Oct 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    10
    Review Days
    133

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    Basic Information

    Device Name
    EMERGE MEDICAL IM NAIL SYSTEM
    K Number
    K141347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Emerge Medical
    Date Received
    May 22, 2014
    Decision Date
    October 2, 2014
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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    Other Clearances by Emerge Medical

    K Number Device Name
    K140107 EMERGE MEDICAL DISTAL RADIUS SET
    K140119 EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
    K140098 EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
    K133536 EMERGE MEDICAL BONE PLATE SYSTEM
    K133541 EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM
    K133452 EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
    K131480 EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
    K122489 EMERGE MEDICAL SOLID BONE SCREWS
    K102343 EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM