BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NUTECH SPINE, INC.

    Reg #: 3009169996 · FEI: 3009169996 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    NUTECH SPINE, INC.
    Registration Number
    3009169996
    FEI Number
    3009169996
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2231 20th Avenue South
    City
    Birmingham
    State
    AL
    ZIP
    35223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092128

    Owner / Operator

    Firm Name
    NuTech Spine, Inc.
    Operator Number
    10036081
    Address
    2231 20th Ave South, Suite 101
    City
    Birmingham
    State
    AL
    Postal Code
    35223
    Country
    US
    Correspondent
    Jeremy Barker

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthopedic Manual Surgical Instrument LXH
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    NuTech Spine Pedicle Screw Spinal System NuFix NuTech NuTech Biologics NuTech Spine SIFix DuALIF NuTech Spine Simplicity Plate

    Establishment Types

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