BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UNIKO PointCloud Knee Instruments

    Reg #: 3019006180 · FEI: 3019006180 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    UNIK ORTHOPEDICS, INC
    Registration Number
    3019006180
    FEI Number
    3019006180
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1701 Fortune Drive, Suite E
    City
    San Jose
    State
    CA
    ZIP
    95131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193312

    Owner / Operator

    Firm Name
    Unik Orthopedics, Inc
    Operator Number
    10081722
    Address
    1701 Fortune Drive, Suite E
    City
    San Jose
    State
    CA
    Postal Code
    95131
    Country
    US
    Correspondent
    Charlie Chi

    Products

    Device Name Product Code
    Knee Arthroplasty Implantation System OOG
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH

    Proprietary Names

    UNIKO PointCloud Knee Instruments

    Establishment Types

    Manufacture Medical Device