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

    TITANIUM HIP TOOL LOCKING PLATE

    K Number: K072175 · Decision Aug 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    11
    Review Days
    15

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    Basic Information

    Device Name
    TITANIUM HIP TOOL LOCKING PLATE
    K Number
    K072175
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthopedic Sciences, Inc.
    Date Received
    August 6, 2007
    Decision Date
    August 21, 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 Orthopedic Sciences, Inc.

    K Number Device Name
    K133018 OSI Q SYSTEM ARTHROSCOPES
    K091398 ARTHROSCOPE
    K063709 TS-BONE HIP TOOL
    K063033 MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT
    K052538 S-BONE HIP TOOL
    K051032 TITANIUM-HIP TOOL
    K051181 CUSTOM-HIP TOOL
    K040493 OUTOLOGOUS SPINAL FIXATION SYSTEM
    K040850 TSY SHOULDER PLATE IMPLANT
    K022139 HIP TOOL IMPLANT
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