BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPINAL ELEMENTS, INC.

    Reg #: 3004893332 · FEI: 3004893332 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    SPINAL ELEMENTS, INC.
    Registration Number
    3004893332
    FEI Number
    3004893332
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3115 Melrose Dr Suite 200
    City
    CARLSBAD
    State
    CA
    ZIP
    92010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082353

    Owner / Operator

    Firm Name
    Spinal Elements
    Operator Number
    9048980
    Address
    3115 Melrose Dr Suite 200
    City
    Carlsbad
    State
    CA
    Postal Code
    92010
    Country
    US
    Correspondent
    Cheryl Allen

    Products

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

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198