BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CORE Shoulder System

    Reg #: 1064858 · FEI: 3008397795 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ANDERSEN SCIENTIFIC, INC.
    Registration Number
    1064858
    FEI Number
    3008397795
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1001 Aviation Parkway, Suite 600
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241470

    Owner / Operator

    Firm Name
    ANDERSEN SCIENTIFIC, INC.
    Operator Number
    9034670
    Address
    1001 Aviation Parkway, Suite 600
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    DARYL - WOODMAN

    Products

    Device Name Product Code
    Shoulder Arthroplasty Implantation System QHE

    Proprietary Names

    CORE Shoulder System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)