BEUDAMED
    FDA Registration Active 🇮🇳 India

    3.5 mm cortical screw, bone plate system,screw fixation system,cannulated screws,4.5 mm cortical screws

    Reg #: 3010303097 · FEI: 3010303097 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Auxein medical Private limited
    Registration Number
    3010303097
    FEI Number
    3010303097
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area,, HSIIDC Sonipat- 131028, Haryana, INDIA
    City
    Sonipat Haryana
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K141680

    Owner / Operator

    Firm Name
    Auxein Medical Pvt Ltd
    Operator Number
    10046810
    Address
    Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area, HSIIDC Sonepat- 131028, Haryana, INDIA, HSIIDC Sonipat- 131028, Haryana, INDIA
    City
    Sonipat
    State
    Haryana
    Postal Code
    131028
    Country
    IN

    US Agent

    Business Name
    510K FDA Inc.
    Contact Name
    Lee Strong
    Address
    156 E Granada Blvd
    City
    Ormond Beach
    State
    FL
    ZIP
    32176
    Country
    US
    Email
    [email protected]
    Phone
    386 8466037

    Products

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

    Proprietary Names

    3.5 mm cortical screw, bone plate system,screw fixation system,cannulated screws,4.5 mm cortical screws AUXEIN- HRS - Plate, fixation, bone HWC - Screw, Fixation, bone AUXEIN- HRS - Plate, fixation, bone HWC - Screw, Fixation, bon

    Establishment Types

    Manufacture Medical Device