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

    VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM

    K Number: K061155 · Decision Sep 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    10
    Review Days
    149

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    Basic Information

    Device Name
    VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
    K Number
    K061155
    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
    Date Received
    April 26, 2006
    Decision Date
    September 22, 2006
    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

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    K050766 EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
    K050937 TRABECULAR METAL ACETABULAR REVISION SHELLS
    K050101 THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
    K042871 TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3
    K043061 THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX