BEUDAMED
    FDA Registration Active 🇺🇸 United States

    APEX Spine System w/CoCr Rods

    Reg #: 3004717358 · FEI: 3004717358 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    SPINECRAFT LLC
    Registration Number
    3004717358
    FEI Number
    3004717358
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    777 Oakmont Ln Suite 200
    City
    Westmont
    State
    IL
    ZIP
    60559
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102488

    Owner / Operator

    Firm Name
    SPINECRAFT LLC
    Operator Number
    9065601
    Address
    777 Oakmont Lane, Suite 200
    City
    Westmont
    State
    IL
    Postal Code
    60559
    Country
    US
    Correspondent
    AMI - AKALLAL-ASAAD

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    APEX Spine System w/CoCr Rods

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device