BEUDAMED
    FDA Registration Active 🇺🇸 United States

    B-ONE ORTHO, CORP.

    Reg #: 3015259876 · FEI: 3015259876 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    B-ONE ORTHO, CORP.
    Registration Number
    3015259876
    FEI Number
    3015259876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3 Wing Drive Suite #259
    City
    Cedar Knolls
    State
    NJ
    ZIP
    07927
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222431

    Owner / Operator

    Firm Name
    b-ONE Ortho, Corp.
    Operator Number
    10059458
    Address
    3 Wing Drive Suite #259
    City
    Cedar Knolls
    State
    NJ
    Postal Code
    07927
    Country
    US
    Correspondent
    Imants Liepins

    Products

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device