BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HiJAK Expandable Cervical Interbody System

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

    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
    K180675

    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
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    HiJAK Expandable Cervical Interbody System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device