BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)

    K Number: K023066 · Decision Nov 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    26
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K Number
    K023066
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4370
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sodemsystems
    Date Received
    September 16, 2002
    Decision Date
    November 25, 2002
    Product Code
    HBB
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HBB Motor, Drill, Pneumatic

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    Other Clearances by Sodemsystems

    K Number Device Name
    K023070 SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K012453 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
    K012457 SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
    K012456 SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
    K993851 SODEM PERFORATOR DRIVE
    K994175 MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
    K935567 SODEM POWER SYSTEM