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

    OsteoMed ExtremiLOCK Wrist Plating System

    K Number: K161041 · Decision May 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    12
    Review Days
    36

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    Basic Information

    Device Name
    OsteoMed ExtremiLOCK Wrist Plating System
    K Number
    K161041
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteomed
    Date Received
    April 13, 2016
    Decision Date
    May 19, 2016
    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 Osteomed

    K Number Device Name
    K203479 ExtremiLOCK Lateral Ankle Fusion Plates
    K162542 OsteoMed PINNACLE Driver
    K162544 OsteoMed PINNACLE Driver
    K152145 OsteoMed ExtremiLOCK Wrist Plating System
    K151195 OsteoMed IMF Screw
    K140978 OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM
    K140283 OSTEOMED EXTREMIFUSE SYSTEM
    K131851 OSTEOMED NEURO RONGEUR
    K133437 1ST MTP PLATE
    K130412 OSTEOMED EXTREMIFUSE SYSTEM
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