BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PNK Total Knee System

    Reg #: 3030446955 · FEI: 3030446955 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SKYVE CO., LTD.
    Registration Number
    3030446955
    FEI Number
    3030446955
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    E1812,Dangsan SKV1center,11,, Dangsan-ro 41-gil,Yeongdeungpo-gu
    City
    Seoul Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K231975

    Owner / Operator

    Firm Name
    Skyve Co., Ltd.
    Operator Number
    10089920
    Address
    E1812,Dangsan SKV1center,11,, Dangsan-ro 41-gil,Yeongdeungpo-gu
    City
    Seoul
    State
    Gyeonggi
    Postal Code
    07217
    Country
    KR

    US Agent

    Business Name
    ComplianceAcuity, Inc.
    Contact Name
    Kevin Randall
    Address
    485 Clinton St.
    City
    Ridgway
    State
    CO
    ZIP
    81432
    Country
    US
    Email
    [email protected]
    Phone
    303 8280844

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    PNK Total Knee System

    Establishment Types

    Manufacture Medical Device