BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYNTHES DISTRACTION OSTEOGENESIS SYSTEM MR CONDITIONAL WITH EXPANDED INDICATIONS

    Reg #: 1828288 · FEI: 1828288 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORCHID UNIQUE
    Registration Number
    1828288
    FEI Number
    1828288
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    ZIP
    48722
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092190

    Owner / Operator

    Firm Name
    Unique Instruments Inc.
    Operator Number
    10042005
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    Postal Code
    48722
    Country
    US

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    SYNTHES DISTRACTION OSTEOGENESIS SYSTEM MR CONDITIONAL WITH EXPANDED INDICATIONS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)