BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEO Pedicle Screw System

    Reg #: 3014003062 · FEI: 3014003062 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    NEO SPINE USA INC.
    Registration Number
    3014003062
    FEI Number
    3014003062
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    411 Hackensack Avenue #200-126
    City
    Hackensack
    State
    NJ
    ZIP
    07601
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212489

    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
    Correspondent
    Jonas Larsson

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Cement, Bone, Vertebroplasty NDN
    Bone Cement, Posterior Screw Augmentation PML

    Proprietary Names

    NEO Pedicle Screw System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198