BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NANOVIS SPINE, LLC

    Reg #: 3009446038 · FEI: 3009446038 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    43
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    NANOVIS SPINE, LLC
    Registration Number
    3009446038
    FEI Number
    3009446038
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5865 E State Road 14
    City
    Columbia City
    State
    IN
    ZIP
    46725
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110442

    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, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Tamp HXG
    Screwdriver HXX
    Extractor HWB
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Awl HWJ
    Thoracolumbosacral Pedicle Screw System NKB
    Bender HXW
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Nanovis Spine Posterior Interbody Fusion Spacer Nanovis Spine Transforminal Interbody Fusion Spacer Nanovis Spine Cervical Interbody Fusion Spacer Nanovis Spine TLIF Implant Trial Nanovis Spine Cervical Implant Trial Ortho Access Spine Transforminal Interbody Fusion Spacer Nanovis Spine Cervical Interbody spacer insertion tool Nanovis Spine PLIF Interbody spacer insertion tool Nanovis Spine TLIF Interbody spacer insertion tool Nanovis Spine PLIF Implant Trial Nanovis FortiCore PLIF Spacer Nanovis Cervical Tamp Nanovis TLIF Tamp Nanovis PLIF Tamp Nanovis Bone Funnel Tamp Nanovis Screwdriver Nanovis Screw Extractor Nanovis FortiBridge Anterior Cervical Plate FortiCore® Nanovis Bone Awl Adaptix PEEK Interbody System with Nanotechnology Nano FortiFix Nano FortiCore Nanovis Plate Bender Anatomic PEEK™ Cervical Fusion System with Nanotechnology Nanovis Paddle Shaver Nanovis Stop Drill Nanovis Lumbar Straight Rasp Nanovis Nerve Hook Nanovis Cervical Packing Block Nanovis TLIF Graft Packing Block Nanovis Bone Funnel Nanovis Slotted Mallet Nanovis Paddle Distractor Nanovis Cervical Rasp Nanovis Bone Plunger Nanovis Tap Nanovis FortiBridge tray and caddy assembly Nanovis FortiBridge cam driver Nanovis FortiBridge drill guide Nanovis FortiBridge distraction adaptor Nanovis FortiBridge Anterior Cervical Plate Screws Nanovis FortiBridge Tap

    Establishment Types

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