BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella

    Reg #: 1722511 · FEI: 1000143502 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ORTHO DEVELOPMENT CORP.
    Registration Number
    1722511
    FEI Number
    1000143502
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12187 SOUTH BUSINESS PARK DR.
    City
    DRAPER
    State
    UT
    ZIP
    84020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131337

    Owner / Operator

    Firm Name
    Ortho Development Corporation
    Operator Number
    9012515
    Address
    12187 South Business Park Drive, --
    City
    Draper
    State
    UT
    Postal Code
    84020
    Country
    US
    Correspondent
    Drew Weaver

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY

    Proprietary Names

    Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella BKS E-Vitalize™ PS Tibial Insert, Vitamin E BKS E-Vitalize®

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198