BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AVS® TL PEEK Spacer

    Reg #: 3004024955 · FEI: 3004024955 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STRYKER SPINE
    Registration Number
    3004024955
    FEI Number
    3004024955
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 PEARL COURT
    City
    ALLENDALE
    State
    NJ
    ZIP
    07401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151726

    Owner / Operator

    Firm Name
    VB Spine, LLC
    Operator Number
    10093189
    Address
    505 Park Avenue, 14th Floor
    City
    New York
    State
    NY
    Postal Code
    10022
    Country
    US
    Correspondent
    Christopher Tortora

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    AVS® TL PEEK Spacer AVS® Navigator PEEK Spacer AVS® AL AVS® UniLIF™ PEEK Spacers AVS ® PL AVS® ALign PEEK Spacers AVS® ARIA PEEK Spacer

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility