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

    IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System

    K Number: K251575 · Decision Sep 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    6
    Review Days
    104

    Basic Information

    Device Name
    IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System
    K Number
    K251575
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Spine
    Date Received
    May 22, 2025
    Decision Date
    September 3, 2025
    Product Code
    OVD
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

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    Other Clearances by Alphatec Spine

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