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

    EMERGE MEDICAL SOLID BONE SCREWS

    K Number: K122489 · Decision Dec 10, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    10
    Review Days
    117

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    Basic Information

    Device Name
    EMERGE MEDICAL SOLID BONE SCREWS
    K Number
    K122489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Emerge Medical
    Date Received
    August 15, 2012
    Decision Date
    December 10, 2012
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Emerge Medical

    K Number Device Name
    K141347 EMERGE MEDICAL IM NAIL SYSTEM
    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
    K102343 EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM