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

    TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET

    K Number: K093127 · Decision Mar 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    11
    Review Days
    153

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    Basic Information

    Device Name
    TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET
    K Number
    K093127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Trabecular Metal Technology
    Date Received
    October 2, 2009
    Decision Date
    March 4, 2010
    Product Code
    MQP
    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
    MQP Spinal Vertebral Body Replacement Device

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    Other Clearances by Zimmer Trabecular Metal Technology

    K Number Device Name
    K133784 VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
    K123602 TM ARDIS INTERBODY SYSTEM INSERTER
    K120990 NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL
    K113561 TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
    K111983 VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
    K103033 TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
    K102896 TRABECULAR METAL TIBIAL CONE AUGMENTS
    K070754 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155
    K071090 TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
    K070382 VISTA -S DEVICE
    Search all 11 clearances from Zimmer Trabecular Metal Technology →