BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Fixed Awl (CPN-00003)

    Reg #: 3021945817 · FEI: 3021945817 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HO MEDI Co., Ltd
    Registration Number
    3021945817
    FEI Number
    3021945817
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ra, je1dong, 307-1 Chilbongsan-Ro
    City
    Yangju Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K220379

    Owner / Operator

    Firm Name
    HO MEDI
    Operator Number
    10092686
    Address
    RA, JE1Dong, 307-1, Chilbongsan-ro
    City
    Yangju-si
    State
    Gyeonggi
    Postal Code
    11448
    Country
    KR
    Correspondent
    MINSU KIM

    US Agent

    Business Name
    MEDYNUS INC
    Contact Name
    David Daewon
    Address
    18 Technology Dr Ste 109
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 9320847

    Products

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

    Proprietary Names

    Fixed Awl (CPN-00003) Drill bit 18 (CPN-00009) Cervical Plate tap (CPN-00004) Cervical plate torque limit driver (CPN-00019) Drill bit 16 (CPN-00008) Plate bender (CPN-00016) Drill Guide Dual (CPN-00013) CERVICAL PLATE IMPLANTS CONTAINER (CPT-00001, AICN-1005-0002, and others) Cervical Plate Screw Implant Caddy (CPR-00002) Prefixation Pin (CPN-00001) Cervical Plate 4 level Implant Caddy (CPR-00006) Cervical plate screw driver ball (CPN-00017) Cervical Plate 1 level Implant Caddy (CPR-00003) Drill bit 12 (CPN-00006) Plate holder (CPN-00015) Cervical Plate 2 level Implant Caddy (CPR-00004) Drill bit 10 (CPN-00005) Drill Guide Variable (CPN-00011) Drill bit 14 (CPN-00007) Drill bit 20 (CPN-00010) Drill Guide Fixed (CPN-00012) Cervical Plate 5 level Implant Caddy (CPR-00007) Modular I handle for Cervical (CPN-00014) Punch Awl (CPN-00002) Cervical plate screw driver centerline (CPN-00018) Cervical Plate Container (CPT-00001) Cervical Plate 3 level Implant Caddy (CPR-00005)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)