BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEXXT SPINE LLC

    Reg #: 3007922509 · FEI: 3007922509 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    32
    Establishment Types
    3
    Classifications
    20

    Registration Details

    Registration Name
    NEXXT SPINE LLC
    Registration Number
    3007922509
    FEI Number
    3007922509
    Status
    Active
    Expiry Year
    2026
    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
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinal Vertebral Body Replacement Device MQP
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Awl HWJ
    Posterior Cervical Screw System NKG
    Thoracolumbosacral Pedicle Screw System NKB
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Tamp HXG
    Orthopedic Stereotaxic Instrument OLO
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Screw, Fixation, Bone HWC
    Sacroiliac Joint Fixation OUR

    Proprietary Names

    Inertia, Facet Fixx, Honour, Struxxure Awl Saxxony Deformity Correxxion Inertia Connexx Nexxt Matrixx Stand Alone Cervical System Struxxure NEXXT MATRIXX® TrellOss-A SA Inertia STRUXXURE-L STRUXXURE-A NEXXT MATRIXX Nexxt Matrixx® System TrellOssTM-A Porous Ti Interbody System Honour Spacer System Tamp TrellOss™-L MPF TrellOss-C SA Struxxure MCS TrellOss MCP Inertia Pedicle Screw System Inertia Navigation Inertia MIS Inertia Connexx Deformity TrellOss Facet Fixx TrellOss-TC Nexxt Matrixx Royal Oak Cervical Plate System Blade Nexxt Matrixx SI

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)