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

    VESITEC DRILL GUIDE

    K Number: K931182 · Decision Jun 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    230
    Applicant Total
    3
    Review Days
    92

    Basic Information

    Device Name
    VESITEC DRILL GUIDE
    K Number
    K931182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    VESITEC MEDICAL, INC.
    Date Received
    March 9, 1993
    Decision Date
    June 9, 1993
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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    Other Clearances by VESITEC MEDICAL, INC.

    K Number Device Name
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    K931181 VESITEC SUTURE PASSER