BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CORE Shoulder System

    Reg #: 3006721341 · FEI: 3006721341 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    LinkBio Corp.
    Registration Number
    3006721341
    FEI Number
    3006721341
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    69 King Street
    City
    Dover
    State
    NJ
    ZIP
    07801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241470

    Owner / Operator

    Firm Name
    LinkBio Corp.
    Operator Number
    10022893
    Address
    69 King Street
    City
    Dover
    State
    NJ
    Postal Code
    07801
    Country
    US
    Correspondent
    Terry Sheridan Powell

    Products

    Device Name Product Code
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Arthroplasty Implantation System QHE

    Proprietary Names

    CORE Shoulder System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility