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

    MACMED PAEDIATRIC INTRAMEDULLARY NAIL

    K Number: K991877 · Decision Aug 6, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    65

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    Basic Information

    Device Name
    MACMED PAEDIATRIC INTRAMEDULLARY NAIL
    K Number
    K991877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innervision, Inc.
    Date Received
    June 2, 1999
    Decision Date
    August 6, 1999
    Product Code
    JDS
    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
    JDS Nail, Fixation, Bone

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