BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IdentiTi Cervical Standalone Interbody System

    Reg #: 2027467 · FEI: 2027467 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ALPHATEC SPINE, INC.
    Registration Number
    2027467
    FEI Number
    2027467
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1950 Camino Vida Roble
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222973

    Owner / Operator

    Firm Name
    ALPHATEC HOLDINGS, INC.
    Operator Number
    9072657
    Address
    1950 Camino Vida Roble
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Brian - Beireis

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE

    Proprietary Names

    IdentiTi Cervical Standalone Interbody System IdentiTi Cervical Porous Ti Interbody System Transcend NanoTec Cervical Interbody System IdentiTi NanoTec Cervical Standalone Interbody Sytem Transcend Cervical PEEK Interbody System IdentiTi NanoTec Cervical Interbody System

    Establishment Types

    Manufacture Medical Device