BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inertia, Facet Fixx, Honour, Struxxure

    Reg #: 3007922509 · FEI: 3007922509 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    NEXXT SPINE LLC
    Registration Number
    3007922509
    FEI Number
    3007922509
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14425 Bergen Blvd Suite B
    City
    Noblesville
    State
    IN
    ZIP
    46060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141376

    Owner / Operator

    Firm Name
    Nexxt Spine LLC
    Operator Number
    10030542
    Address
    14425 Bergen Blvd Suite B
    City
    Noblesville
    State
    IN
    Postal Code
    46060
    Country
    US
    Correspondent
    Andrew Elsbury

    Products

    Device Name Product Code
    System, Facet Screw Spinal Device MRW
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Spinal Vertebral Body Replacement Device MQP
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    Inertia, Facet Fixx, Honour, Struxxure

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device