BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 16MM SELF-TAPPING

    Reg #: 1000517406 · FEI: 1000517406 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    80
    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
    K083032

    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

    PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 16MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 80MM PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 65MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 38MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 44MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 18MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 10MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 62MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 28MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 100MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 30MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 110MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 90MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 64MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 85MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 34MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 50MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 14MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 45MM PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 12MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 48MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 32MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 28MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 40MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 36MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 30MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 42MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 80MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 46MM SELF-TAPPING 5.7MM CANN LCK SCRW 20MM PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 90MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 18MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 68MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 30MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 60MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 76MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 55MM PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 40MM PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 14MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 72MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 70MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 20MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 75MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 24MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 22MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 50MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 95MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 38MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 70MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 56MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 54MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 55MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 58MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 85MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 20MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 25MM PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 60MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 74MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 95MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 32MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 24MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 45MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 20MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 34MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 50MM PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 65MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 26MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 90MM PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 22MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 16MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 52MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 36MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 75MM PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 35MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 70MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 60MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 66MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 78MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 40MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 26MM SELF-TAPPING

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)