BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Certain Flat Implant Cover Screw

    Reg #: 1038806 · FEI: 1038806 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOMET 3i, LLC
    Registration Number
    1038806
    FEI Number
    1038806
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4555 Riverside Drive
    City
    Palm Beach Gardens
    State
    FL
    ZIP
    33410
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063341

    Owner / Operator

    Firm Name
    Biomet 3i
    Operator Number
    1038806
    Address
    4555 Riverside Drive, --
    City
    Palm Beach Gardens
    State
    FL
    Postal Code
    33410
    Country
    US
    Correspondent
    Ruth Lopez

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    Certain Flat Implant Cover Screw Certain PREVAIL Implant OSSEOTITE XP Certain Implant Certain Implant Headless Cover Screw Full OSSEOTITE Certain Implant Full OSSEOTITE Tapered Certain Implant Certain MicroMini Flat Implant Cover Screw Certain Implant Cover Screw OSSEOTITE Tapered Certain Implant Certain Cover Screw Full OSSEOTITE XP Certain Implant NanoTite Tapered Certain Implant Certain Implant Straight Cover Screw OSSEOTITE Certain Implant

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device