BEUDAMED
    FDA Registration Active 🇺🇸 United States

    6.5 16MM THREAD CANCELLOUS SCREW 105MM

    Reg #: 1000517406 · FEI: 1000517406 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    73
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Paragon Medical Inc.
    Registration Number
    1000517406
    FEI Number
    1000517406
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    125 W 1000 S
    City
    Smithfield
    State
    UT
    ZIP
    84335
    Country
    US

    Regulatory Submissions

    510(k) Number
    K993106

    Owner / Operator

    Firm Name
    Paragon Medical
    Operator Number
    9011072
    Address
    8 Matchett Dr., --
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    Stephane Langlois

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    6.5 16MM THREAD CANCELLOUS SCREW 105MM CANNULATED HIP PIN 95MM CANNULATED HIP PIN 75MM 6.5 16MM THREAD CANCELLOUS SCREW 55MM 6.5 FULLY THREADED CANCELLOUS SCREW 140MM 6.5 16MM THREAD CANCELLOUS SCREW 140MM 6.5 FULLY THREADED CANCELLOUS SCREW 25MM 6.5 16MM THREAD CANCELLOUS SCREW 90MM 6.5 16MM THREAD CANCELLOUS SCREW 100MM CANNULATED HIP PIN 70MM 6.5 16MM THREAD CANCELLOUS SCREW 95MM 6.5 FULLY THREADED CANCELLOUS SCREW 100MM 6.5 FULLY THREADED CANCELLOUS SCREW 60MM 6.5 FULLY THREADED CANCELLOUS SCREW 120MM 6.5 FULLY THREADED CANCELLOUS SCREW 85MM 6.5 FULLY THREADED CANCELLOUS SCREW 90MM 6.5 16MM THREAD CANCELLOUS SCREW 115MM CANNULATED HIP PIN 120MM 6.5 16MM THREAD CANCELLOUS SCREW 110MM 6.5 FULLY THREADED CANCELLOUS SCREW 130MM CANNULATED HIP PIN 100MM 6.5 FULLY THREADED CANCELLOUS SCREW 35MM 6.5 FULLY THREADED CANCELLOUS SCREW 30MM 6.5 FULLY THREADED CANCELLOUS SCREW 40MM CANNULATED HIP PIN 80MM 6.5 FULLY THREADED CANCELLOUS SCREW 105MM CANNULATED HIP PIN 105MM 6.5 16MM THREAD CANCELLOUS SCREW 125MM CANNULATED HIP PIN 135MM 6.5 FULLY THREADED CANCELLOUS SCREW 150MM 6.5 FULLY THREADED CANCELLOUS SCREW 115MM 6.5 FULLY THREADED CANCELLOUS SCREW 45MM CANNULATED HIP PIN 130MM 6.5 16MM THREAD CANCELLOUS SCREW 80MM 6.5 FULLY THREADED CANCELLOUS SCREW 95MM CANNULATED HIP PIN 55MM 6.5 16MM THREAD CANCELLOUS SCREW 50MM 6.5 16MM THREAD CANCELLOUS SCREW 40MM 6.5 16MM THREAD CANCELLOUS SCREW 65MM 6.5 16MM THREAD CANCELLOUS SCREW 135MM 6.5 FULLY THREADED CANCELLOUS SCREW 110MM CANNULATED HIP PIN 50MM 6.5 FULLY THREADED CANCELLOUS SCREW 125MM 6.5 FULLY THREADED CANCELLOUS SCREW 70MM CANNULATED HIP PIN 90MM 6.5 16MM THREAD CANCELLOUS SCREW 35MM 6.5 FULLY THREADED CANCELLOUS SCREW 145MM 6.5 16MM THREAD CANCELLOUS SCREW 85MM 6.5 FULLY THREADED CANCELLOUS SCREW 65MM CANNULATED HIP PIN 115MM 6.5 FULLY THREADED CANCELLOUS SCREW 75MM CANNULATED HIP PIN 65MM 6.5 FULLY THREADED CANCELLOUS SCREW 55MM CANNULATED HIP PIN 35MM CANNULATED HIP PIN 85MM 6.5 16MM THREAD CANCELLOUS SCREW 120MM 6.5 FULLY THREADED CANCELLOUS SCREW 80MM 6.5 FULLY THREADED CANCELLOUS SCREW 135MM CANNULATED HIP PIN 110MM 6.5 FULLY THREADED CANCELLOUS SCREW 50MM 6.5 16MM THREAD CANCELLOUS SCREW 130MM CANNULATED HIP PIN 125MM 6.5 16MM THREAD CANCELLOUS SCREW 60MM 6.5 16MM THREAD CANCELLOUS SCREW 150MM 6.5 16MM THREAD CANCELLOUS SCREW 70MM 6.5 16MM THREAD CANCELLOUS SCREW 45MM CANNULATED HIP PIN 30MM 6.5 16MM THREAD CANCELLOUS SCREW 145MM CANNULATED HIP PIN 40MM CANNULATED HIP PIN 60MM 6.5 16MM THREAD CANCELLOUS SCREW 30MM 6.5 16MM THREAD CANCELLOUS SCREW 75MM CANNULATED HIP PIN 45MM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)