BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEO SPINE USA INC.

    Reg #: 3014003062 · FEI: 3014003062 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    69
    Establishment Types
    1
    Classifications
    14

    Registration Details

    Registration Name
    NEO SPINE USA INC.
    Registration Number
    3014003062
    FEI Number
    3014003062
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    411 Hackensack Avenue #200-126
    City
    Hackensack
    State
    NJ
    ZIP
    07601
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171582

    Owner / Operator

    Firm Name
    Neo Spine USA Inc.
    Operator Number
    10056088
    Address
    411 Hackensack Avenue #200-126
    City
    Hackensack
    State
    NJ
    Postal Code
    07601
    Country
    US

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Tap, Bone HWX
    Bone Cement, Posterior Screw Augmentation PML
    Cement, Bone, Vertebroplasty NDN
    Light, Surgical, Instrument FSQ
    Dispenser, Cement KIH
    Screwdriver HXX
    Retractor GAD
    Bone Cement LOD
    Bender HXW
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Orthopedic Manual Surgical Instrument LXH
    Probe HXB

    Proprietary Names

    Neo Pedicle Screw System Sterile container Tap kit for Neo Pedicle Screw System Neo Flex Light Cement pusher NEO Pedicle Screw System Screwdriver Adaptor - 1/4", NS Ratchet Handle - 1/4", NS Ratchet Handle - Hudson, NS Set screwdriver Screwdriver Converter - Hudson, NS Screwdriver Adaptor - AO, NS Screwdriver Converter - AO, NS Screwdriver Handle, NS Screwdriver kit Ratchet Screwdriver, NS Screwdriver Adaptor - Hudson, NS Set-screwdriver (10x1) MIS Posterior retractor kit 60mm MIS Posterior retractor lateral blade kit 50mm MIS Posterior retractor lateral blade kit 60mm MIS Posterior retractor lateral blade kit 70mm MIS Posterior retractor kit 80mm MIS Posterior retractor access kit Lateral retractor kit 180mm Posterior retractor kit 70mm Posterior retractor kit 60mm Posterior retractor access kit Lateral retractor kit 160mm Lateral retractor access kit Posterior retractor kit 80mm Lateral retractor kit 120mm Lateral retractor kit 140mm Posterior retractor kit 50mm Posterior retractor kit 40mm MIS Posterior retractor lateral blade kit 90mm MIS Posterior retractor kit 70mm MIS Posterior retractor lateral blade kit 40mm MIS Posterior retractor lateral blade kit 80mm MIS Posterior retractor kit 40mm MIS Posterior retractor kit 50mm BonOs Inject Rod Bender NS Neo Cage System Ratchet T-Handle - 1/4", NS T-Handle Kit Single Use Pedicle marker (2x) Cage puller Posterior instrument kit Pedicle marker Cage Bent Curette Kit Cage holder Revision Guide (10x1) Removal Kit Non-constraint torque limiter (10x) Non-constraint torque limiter Cage Pusher Kit Cage Instrument Kit Compressor Distractor Kit Cage straight curette kit Scraper / distractor Screw Guide Remover Revision Guide K-wire Kit Rod Rotation Wrench Marker Base (10x1) Pedicle Screw Instrument Kit Persuader Steffee

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198