BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Adaptix PEEK Interbody System with Nanotechnology

    Reg #: 3009446038 · FEI: 3009446038 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NANOVIS SPINE, LLC
    Registration Number
    3009446038
    FEI Number
    3009446038
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5865 E State Road 14
    City
    Columbia City
    State
    IN
    ZIP
    46725
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241605

    Owner / Operator

    Firm Name
    Nanovis, LLC
    Operator Number
    10039378
    Address
    5865 E State Road 14
    City
    Columbia City
    State
    IN
    Postal Code
    46725
    Country
    US

    Products

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

    Proprietary Names

    Adaptix PEEK Interbody System with Nanotechnology

    Establishment Types

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