BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASphere (hip), M-Spec

    Reg #: 1818910 · FEI: 1818910 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    DEPUY ORTHOPAEDICS, INC.
    Registration Number
    1818910
    FEI Number
    1818910
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    700 ORTHOPAEDIC DR.
    City
    WARSAW
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082585

    Owner / Operator

    Firm Name
    DePuy Synthes, Inc.
    Operator Number
    1818910
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    ASphere (hip), M-Spec

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility