BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Apelo® MIS Pedicle Screw System

    Reg #: 3003855635 · FEI: 3003855635 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ATLAS SPINE INC.
    Registration Number
    3003855635
    FEI Number
    3003855635
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1555 Jupiter Park Dr Ste 1
    City
    JUPITER
    State
    FL
    ZIP
    33458
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110842

    Owner / Operator

    Firm Name
    ATLAS SPINE INC.
    Operator Number
    9053705
    Address
    1555 JUPITER PARK DR., STE. 1, --
    City
    Jupiter
    State
    FL
    Postal Code
    33458
    Country
    US
    Correspondent
    Thomas G Smith

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    Apelo® MIS Pedicle Screw System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device