BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Restoris MCK Tibial Baseplate

    Reg #: 3017410889 · FEI: 3005985723 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    MAKO SURGICAL CORP.
    Registration Number
    3017410889
    FEI Number
    3005985723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3365 ENTERPRISE AVE
    City
    Weston
    State
    FL
    ZIP
    33331
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220930

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR

    Proprietary Names

    Restoris MCK Tibial Baseplate Restoris MCK Patellofemoral Component Restoris MCK Tibial Onlay Insert Restoris MCK Femoral Component Restoris MCK X3 Tibial Onlay Insert Restoris MCK Patella Resurfacing Round Dome

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility