BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    INNESIS PEEK CERVICAL CAGE

    Reg #: 3004176895 · FEI: 3004176895 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BK MEDITECH CO., LTD.
    Registration Number
    3004176895
    FEI Number
    3004176895
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    58, Eunhaengnamu-ro, Yanggam-myeon
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K132483

    Owner / Operator

    Firm Name
    BK MEDITECH CO., LTD.
    Operator Number
    9059102
    Address
    58, Eunhaengnamu-ro, Yanggam-myeon, --
    City
    Hwaseong-si
    State
    Gyeonggi
    Postal Code
    18633
    Country
    KR
    Correspondent
    BYOUNGJUN - PARK

    US Agent

    Business Name
    Paladin Medical, Inc.
    Contact Name
    Elaine Duncan
    Address
    415 Valley View Trail
    City
    Houlton
    State
    WI
    ZIP
    54082
    Country
    US
    Email
    [email protected]
    Phone
    715 5496035

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    INNESIS PEEK CERVICAL CAGE

    Establishment Types

    Manufacture Medical Device