BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biocore9 Humeral Head Resurfacing System

    Reg #: 3020162561 · FEI: 3020162561 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOCORE9 LLC
    Registration Number
    3020162561
    FEI Number
    3020162561
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30 Broad Street, Ste 3 B
    City
    Denville
    State
    NJ
    ZIP
    07834
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193122

    Owner / Operator

    Firm Name
    Biocore9 LLC
    Operator Number
    10082626
    Address
    30 Broad Street, Ste 3 B
    City
    Denville
    State
    NJ
    Postal Code
    07834
    Country
    US
    Correspondent
    Stan Matlak

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    Biocore9 Humeral Head Resurfacing System

    Establishment Types

    Manufacture Medical Device