BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OneLIF™ Interbody Fusion System

    Reg #: 3020307303 · FEI: 3020307303 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NOVAPPROACH SPINE, LLC
    Registration Number
    3020307303
    FEI Number
    3020307303
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13900 Tech City Circle, Suite 300
    City
    Alachua
    State
    FL
    ZIP
    32615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211769

    Owner / Operator

    Firm Name
    NovApproach Spine, LLC
    Operator Number
    10082697
    Address
    13900 Tech City Circle, Suite 300
    City
    Alachua
    State
    FL
    Postal Code
    32615
    Country
    US
    Correspondent
    Ronald P Green

    Products

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

    Proprietary Names

    OneLIF™ Interbody Fusion System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility