BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHOCIRCLE

    Reg #: 3009132077 · FEI: 3009132077 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ORTHOCIRCLE
    Registration Number
    3009132077
    FEI Number
    3009132077
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    15 E Montgomery Xrd Ste 3
    City
    Savannah
    State
    GA
    ZIP
    31406
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193472

    Owner / Operator

    Firm Name
    OrthoCircle North America, LLC
    Operator Number
    10036579
    Address
    15 E Montgomery Crossroads, Ste 3
    City
    Savannah
    State
    GA
    Postal Code
    31406
    Country
    US
    Correspondent
    Matthew Albert

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility