BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ULRICH MEDICAL USA, INC.

    Reg #: 3005823819 · FEI: 3005532635 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    ULRICH MEDICAL USA, INC.
    Registration Number
    3005823819
    FEI Number
    3005532635
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3700 East Plano Parkway, Suite 200
    City
    Plano
    State
    TX
    ZIP
    75074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191932

    Owner / Operator

    Firm Name
    ULRICH MEDICAL USA, INC.
    Operator Number
    9062154
    Address
    3700 East Plano Parkway, Suite 200, --
    City
    Plano
    State
    TX
    Postal Code
    75074
    Country
    US
    Correspondent
    Eric - Gibbs

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Spinal Vertebral Body Replacement Device MQP
    Orthopedic Stereotaxic Instrument OLO
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Tap, Bone HWX
    Bone Cement, Posterior Screw Augmentation PML
    Orthopedic Manual Surgical Instrument LXH
    Appliance, Fixation, Spinal Interlaminal KWP
    Caliper KTZ
    Posterior Cervical Screw System NKG
    Screwdriver HXX
    Impactor HWA

    Proprietary Names

    Momentum Posterior Spinal Fixation System Solidity Vertebral Body Replacement uNion MAX drill V-Steady Cement uCerv Flux C hyperlordotic Control Handle Momentum MIS uNion Cervical Plate System Momentum Deformity Cortium Universal OCT Spinal Fixation System screwdriver Angled Pusher

    Establishment Types

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