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

    THEKEN REVEAL VBR SYSTEM

    K Number: K050058 · Decision May 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    6
    Review Days
    126

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    Basic Information

    Device Name
    THEKEN REVEAL VBR SYSTEM
    K Number
    K050058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Theken Surgical,Llc
    Date Received
    January 11, 2005
    Decision Date
    May 17, 2005
    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 Theken Surgical,Llc

    K Number Device Name
    K032064 THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
    K012462 THEKEN LARGE CEMENT RESTRICTOR
    K012278 THEKEN SMALL CEMENT RESTRICTOR
    K010466 TETHER ACFS
    K983622 BODYFORM THORACO-LUMBAR FIXATION SYSTEM