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

    ARC SURGICAL BIOTRAK SCREW

    K Number: K061763 · Decision Sep 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    ARC SURGICAL BIOTRAK SCREW
    K Number
    K061763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arc Surgical, LLC
    Date Received
    June 22, 2006
    Decision Date
    September 19, 2006
    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 Arc Surgical, LLC

    K Number Device Name
    K141559 V-GUIDE FOR VENTRICULOSTOMIES
    K071616 ARC SURGICAL BIOTRAK PIN SYSTEM
    K063244 ARC SURGICAL BONE REDUCTION SCREW
    K043176 ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM