BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CORE Shoulder System

    Reg #: 3014967969 · FEI: 3014967969 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PACKAGING COMPLIANCE MEDICAL, LLC
    Registration Number
    3014967969
    FEI Number
    3014967969
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4334 Brockton Dr SE, Suite E
    City
    Kentwood
    State
    MI
    ZIP
    49512
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241470

    Owner / Operator

    Firm Name
    Packaging Compliance Medical, LLC
    Operator Number
    10082615
    Address
    4334 Brockton Dr SE, Suite E
    City
    Kentwood
    State
    MI
    Postal Code
    49512
    Country
    US
    Correspondent
    Matthew Lapham

    Products

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

    Proprietary Names

    CORE Shoulder System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)