BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Single Hole Staple

    Reg #: 1531174 · FEI: 3002993297 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NORWOOD MEDICAL LLC
    Registration Number
    1531174
    FEI Number
    3002993297
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2122 Winners Circle
    City
    Dayton
    State
    OH
    ZIP
    45404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041205

    Owner / Operator

    Firm Name
    Norwood Medical
    Operator Number
    10042115
    Address
    2122 Winners Circle
    City
    Dayton
    State
    OH
    Postal Code
    45404
    Country
    US
    Correspondent
    Jennifer L Kleinwaechter

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    Single Hole Staple Dual Hole Staple, Rostral, Large Crossconnector 14mm Monoaxial Screw 5.5 x 6 X 40mm Monoaxial Screw 5.5 x 6 X 50mm Monoaxial Screw 5.5 x 7 X 50mm Monoaxial Screw 5.5 x 6 X 32.5mm Crossconnector 13mm Crossconnector Set Screw Monoaxial Screw 5.5 x 7 X 45mm Monoaxial Screw 5.5 x 7 X 40mm Monoaxial Screw 5.5 x 6 X 22.5mm Dual Hole Staple, Rostral, Small Monoaxial Screw 5.5 x 6 X 55mm Monoaxial Screw 5.5 x 7 X 25mm Crossconnector 18mm Dual Hole Staple, Rostral, Medium Monoaxial Screw 5.5 x 6 X 35mm Monoaxial Screw 5.5 x 5 X 30mm Monoaxial Screw 5.5 x 7 X 30mm Monoaxial Screw 5.5 x 7 X 35mm Monoaxial Screw 5.5 x 6 X 27.5mm Monoaxial Screw 5.5 x 7 X 60mm Monoaxial Screw 5.5 x 6 X 30mm Dual Hole Staple, Caudal, Medium Monoaxial Screw 5.5 x 6 X 37.5mm Monoaxial Screw 5.5 x 6 X 45mm Crossconnector 16mm Monoaxial Screw 5.5 x 5 X 40mm Monoaxial Screw 5.5 x 5 X 35mm Dual Hole Staple, Caudal, Small Crossconnector 15mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)