BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Neuro & Craniofacial Fixation System

    Reg #: 3004719693 · FEI: 3004719693 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INNOVASIS, INC.
    Registration Number
    3004719693
    FEI Number
    3004719693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    614 E 3900 S
    City
    SALT LAKE CITY
    State
    UT
    ZIP
    84107
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141452

    Owner / Operator

    Firm Name
    INNOVASIS, INC.
    Operator Number
    9063224
    Address
    614 EAST 3900 SOUTH, --
    City
    Salt Lake City
    State
    UT
    Postal Code
    84107
    Country
    US

    Products

    Device Name Product Code
    Cover, Burr Hole GXR
    Fastener, Plate, Cranioplasty HBW
    Plate, Cranioplasty, Preformed, Alterable GWO

    Proprietary Names

    Neuro & Craniofacial Fixation System

    Establishment Types

    Repack or Relabel Medical Device