BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System

    Reg #: 2183449 · FEI: 2183449 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ORTHOFIX US LLC
    Registration Number
    2183449
    FEI Number
    2183449
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3451 Plano Parkway
    City
    Lewisville
    State
    TX
    ZIP
    75056
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162446

    Owner / Operator

    Firm Name
    Orthofix US LLC
    Operator Number
    10028162
    Address
    3451 Plano Parkway
    City
    Lewisville
    State
    TX
    Postal Code
    75056
    Country
    US

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinal Vertebral Body Replacement Device MQP

    Proprietary Names

    FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility