BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vitality Transverse Connector Assembly Fixed

    Reg #: 3001239363 · FEI: 3001239363 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    3D MEDICAL MANUFACTURING, INC. (dba Tecomet)
    Registration Number
    3001239363
    FEI Number
    3001239363
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1006 West 15th Street
    City
    Riviera Beach
    State
    FL
    ZIP
    33404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150896

    Owner / Operator

    Firm Name
    3D Medical Manufacturing, inc. DBA Tecomet
    Operator Number
    10043250
    Address
    2001 Congress Avenue
    City
    Riviera Beach
    State
    FL
    Postal Code
    33404
    Country
    US
    Correspondent
    Vanesa Fields

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH

    Proprietary Names

    Vitality Transverse Connector Assembly Fixed Vitality Closure Top Shear Off Vitality Closure Top Torque Limit Vitality Top Loading Polyaxial Screw Assy Vitality Transverse Connector Assembly Adjustable

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)