BEUDAMED
    FDA Registration Active 🇨🇳 China

    TAP RBT071575 RG CORTICAL 7.5 AWL-TIP SHORT

    Reg #: 3007539489 · FEI: 3007539489 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Paragon Medical Device (Changzhou) Co., Ltd.
    Registration Number
    3007539489
    FEI Number
    3007539489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3A GDH Industrial Park, No. 16 Chuangye Road
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K210637

    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

    US Agent

    Business Name
    Paragon Medical
    Contact Name
    Stephane Langlois
    Address
    8 Matchett Dr
    City
    Pierceton
    State
    IN
    ZIP
    46562
    Country
    US
    Email
    [email protected]
    Phone
    435 5355456

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    TAP RBT071575 RG CORTICAL 7.5 AWL-TIP SHORT CORTICAL TAP, DUAL LEAD, NAVIGATED-?7.5MM TAP, CORTICAL DUAL LEAD-?6.5MM CORTICAL TAP, DUAL LEAD, NAVIGATED-?4.5MM TAP RBT071545 RG CORTICAL 4.5 AWL-TIP SHORT TAP, CORTICAL DUAL LEAD-?7.5MM TAP, CORTICAL DUAL LEAD-?5.5MM TAP RBT071555 RG CORTICAL 5.5 AWL-TIP SHORT TAP RBT071665 RG CORTICAL 6.5 AWL-TIP LONG TAP RBT071675 RG CORTICAL 7.5 AWL-TIP LONG TAP RBT071655 RG CORTICAL 5.5 AWL-TIP LONG CORTICAL TAP, DUAL LEAD, NAVIGATED-?6.5MM CORTICAL TAP, DUAL LEAD, NAVIGATED-?5.5MM TAP RBT071645 RG CORTICAL 4.5 AWL-TIP LONG TAP, CORTICAL DUAL LEAD-?4.5MM TAP RBT071565 RG CORTICAL 6.5 AWL-TIP SHORT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)