BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ONKOS SURGICAL, INC.

    Reg #: 3013450937 · FEI: 3013450937 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    ONKOS SURGICAL, INC.
    Registration Number
    3013450937
    FEI Number
    3013450937
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    77 E HALSEY RD
    City
    Parsippany
    State
    NJ
    ZIP
    07054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223348

    Owner / Operator

    Firm Name
    Onkos Surgical
    Operator Number
    10054049
    Address
    77 East Halsey Rd
    City
    Parsippany
    State
    NJ
    Postal Code
    07054
    Country
    US
    Correspondent
    Len Tokish

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Template HWT
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Limb And Joint Salvage Device With Coating For Bacteria Reduction QZZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Tray, Surgical, Instrument FSM

    Proprietary Names

    My3D Personalized Pelvic Reconstruction ELEOS ELEOS™ Limb Salvage System with NanoCept® Technology NanoCept® ELEOS Limb Salvage System with BioGrip JTS Extendible Implant and related instrumentation JTS Extendible Implant and associated instrumentation ELEOS Limb Salvage System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility