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

    SBI RHEAD PLATING SYSTEM

    K Number: K071549 · Decision Aug 7, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    20
    Review Days
    62

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    Basic Information

    Device Name
    SBI RHEAD PLATING SYSTEM
    K Number
    K071549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Small Bone Innovations, Inc.
    Date Received
    June 6, 2007
    Decision Date
    August 7, 2007
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Small Bone Innovations, Inc.

    K Number Device Name
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    K092754 SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
    K093550 MINI RAIL EXTERNAL FIXATOR SYSTEM
    K073635 SBI SR MTP TOE IMPLANT
    K071541 SBI TWISTOFIX
    K063635 SBI FOREFOOT SET
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