BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kinos Axiom Total Ankle System

    Reg #: 3014833750 · FEI: 3014833750 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    restor3d, inc.
    Registration Number
    3014833750
    FEI Number
    3014833750
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4001 NC Hwy 54, Suite 2160
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232595

    Owner / Operator

    Firm Name
    restor3d, inc.
    Operator Number
    10058270
    Address
    4001 NC Hwy 54, Suite 3160
    City
    Durham
    State
    NC
    Postal Code
    27709
    Country
    US
    Correspondent
    Brianna Prindle

    Products

    Device Name Product Code
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN

    Proprietary Names

    Kinos Axiom Total Ankle System

    Establishment Types

    Manufacture Medical Device