BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spiggle and Theis Ossicular Replacement

    Reg #: 1052728 · FEI: 1000113735 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INVOTEC INTERNATIONAL, INC.
    Registration Number
    1052728
    FEI Number
    1000113735
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6833 PHILLIPS INDUSTRIAL BLVD.
    City
    Jacksonville
    State
    FL
    ZIP
    32256
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030492

    Owner / Operator

    Firm Name
    INVOTEC INTERNATIONAL, INC.
    Operator Number
    9000512
    Address
    6833 PHILLIPS INDUSTRIAL BLVD., --
    City
    Jacksonville
    State
    FL
    Postal Code
    32256
    Country
    US
    Correspondent
    JEFFREY L AULL

    Products

    Device Name Product Code
    Prosthesis, Partial Ossicular Replacement ETB
    Replacement, Ossicular Prosthesis, Total ETA

    Proprietary Names

    Spiggle and Theis Ossicular Replacement

    Establishment Types

    Repack or Relabel Medical Device