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

    TRANS1 INTERBODY FUSION SYSTEM

    K Number: K120991 · Decision Aug 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    9
    Review Days
    143

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    Basic Information

    Device Name
    TRANS1 INTERBODY FUSION SYSTEM
    K Number
    K120991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trans1 Incorporated
    Date Received
    April 2, 2012
    Decision Date
    August 23, 2012
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Trans1 Incorporated

    K Number Device Name
    K102334 TRANS1 AXIALIF PLUS
    K100210 TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T
    K092124 AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II
    K073643 TRANS1 AXIALIF 2-LEVEL OR II SYSTEM
    K073515 TRANS1 FACET SCREW
    K073514 TRANS1 AXIAL FIXATON SYSTEM
    K051856 TRANS1 FACET SCREWS
    K050965 TRANS1 AXIALIF SYSTEM