BEUDAMED
    FDA Registration Active 🇺🇸 United States

    B-ONE ORTHO, CORP.

    Reg #: 3015259876 · FEI: 3015259876 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    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
    K240528

    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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Establishment Types

    Manufacture Medical Device