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

    SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)

    K Number: K012457 · Decision Oct 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    25
    Applicant Total
    8
    Review Days
    82

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    Basic Information

    Device Name
    SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
    K Number
    K012457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4360
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sodemsystems
    Date Received
    August 1, 2001
    Decision Date
    October 22, 2001
    Product Code
    HBC
    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
    HBC Motor, Drill, Electric

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    Other Clearances by Sodemsystems

    K Number Device Name
    K023070 SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K023066 DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K012453 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC 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