BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

    Reg #: 1529009 · FEI: 1000149660 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    APS MATERIALS, INC.
    Registration Number
    1529009
    FEI Number
    1000149660
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4011 RIVERSIDE DR.
    City
    DAYTON
    State
    OH
    ZIP
    45405
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182516

    Owner / Operator

    Firm Name
    APS Materials, Inc
    Operator Number
    9023611
    Address
    4011 Riverside Dr, Dayton OH
    City
    Dayton
    State
    OH
    Postal Code
    45405
    Country
    US
    Correspondent
    Chris Page

    Products

    Device Name Product Code
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC

    Proprietary Names

    Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)