BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Phantom Fukushima/Mastability Systems

    Reg #: 3005726885 · FEI: 3005726885 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TEDAN SURGICAL INNOVATIONS, INC.
    Registration Number
    3005726885
    FEI Number
    3005726885
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12320 Cardinal Meadow Drive, Suite #150
    City
    Sugar Land
    State
    TX
    ZIP
    77478
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161318

    Owner / Operator

    Firm Name
    TEDAN SURGICAL INNOVATIONS, INC.
    Operator Number
    9086980
    Address
    12320 Cardinal Meadow Drive, Suite #150
    City
    Sugar Land
    State
    TX
    Postal Code
    77478
    Country
    US

    Products

    Device Name Product Code
    Retractor, Self-Retaining, For Neurosurgery GZT

    Proprietary Names

    Phantom Fukushima/Mastability Systems

    Establishment Types

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