BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Genesis Screw-In Anchor (B type)

    Reg #: 3025318945 · FEI: 3025318945 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERICO Co., Ltd.
    Registration Number
    3025318945
    FEI Number
    3025318945
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    173, Wangnim-ro
    City
    Gwangju-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230892

    Owner / Operator

    Firm Name
    STERICO Co., Ltd.
    Operator Number
    10091816
    Address
    173, Wangnim-ro
    City
    Gwangju-si
    State
    Gyeonggi
    Postal Code
    12773
    Country
    KR

    US Agent

    Business Name
    Onbix Corp US
    Contact Name
    Uju Krallum
    Address
    102 N G St Unit 105
    City
    Tacoma
    State
    WA
    ZIP
    98403
    Country
    US
    Email
    [email protected]
    Phone
    843 5828036

    Products

    Device Name Product Code
    Fastener, Fixation, Biodegradable, Soft Tissue MAI

    Proprietary Names

    Genesis Screw-In Anchor (B type) Fixone Biocomposite Anchor (B,KC,S,SL,N,BN type) Genesis Dual Thread Screw-In Anchor (N type) Genesis Push-In Suture Anchor (S type) AlternatiV+ Screw-In Anchor (BN type)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)