BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DigiFix

    Reg #: 3010860227 · FEI: 3010860227 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    VIRAK ORTHOPEDICS LLC
    Registration Number
    3010860227
    FEI Number
    3010860227
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    345 Main St, Ste 202
    City
    Madison
    State
    NJ
    ZIP
    07940
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192465

    Owner / Operator

    Firm Name
    Virak Orthopedics LLC
    Operator Number
    10046599
    Address
    345 Main St, Ste 202
    City
    Madison
    State
    NJ
    Postal Code
    07940
    Country
    US
    Correspondent
    Virak Tan

    Products

    Device Name Product Code
    Component, Traction, Invasive JEC

    Proprietary Names

    DigiFix

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility