BEUDAMED
    FDA Registration Active 🇺🇸 United States

    5.5/6 MAS 5.5 x 30,35,40,45,50 HA Coated

    Reg #: 3011277306 · FEI: 3011277306 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Orchid Detroit
    Registration Number
    3011277306
    FEI Number
    3011277306
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    23149 Commerce Drive
    City
    Farmington Hills
    State
    MI
    ZIP
    48335
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113174

    Owner / Operator

    Firm Name
    CEP Bio-Coat, LLC D/B/A Orchid Orthopedic Solutions, LLC
    Operator Number
    10042681
    Address
    23149 Commerce Dr
    City
    Farmington Hills
    State
    MI
    Postal Code
    48335
    Country
    US
    Correspondent
    Ray Maroofian

    Products

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

    Proprietary Names

    5.5/6 MAS 5.5 x 30,35,40,45,50 HA Coated 5.5/6 MAS 8.5 x 35,40,45,50 HA Coated 5.5/6 MAS 6.5 x 30,35,40,45,50,55 HA Coated 5.5/6 MAS 7.5 x 40,45,50,55 HA Coated

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)