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

    ACCULIF TL AND PL CAGE

    K Number: K132505 · Decision Sep 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    9
    Review Days
    31

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    Basic Information

    Device Name
    ACCULIF TL AND PL CAGE
    K Number
    K132505
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coalign Innovations, Inc.
    Date Received
    August 12, 2013
    Decision Date
    September 12, 2013
    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 Coalign Innovations, Inc.

    K Number Device Name
    K131443 COALIGN INNOVATIONS ACCULIF XL IBF CAGE
    K130194 ACCULIF XL CAGE
    K123281 ACCULIF TL-PEEK CAGE
    K123752 ACCULIF TL AND PL CAGE
    K121683 ACCULIF TL CAGE
    K113465 ACCULIF TL CAGE
    K112095 ACCULIF TL-PEEK IBF CAGE
    K110270 ACCULIF CAGE