BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Avitus Orthopaedics, Inc

    Reg #: 3011504993 · FEI: 3011504993 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Avitus Orthopaedics, Inc
    Registration Number
    3011504993
    FEI Number
    3011504993
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 Armstrong Rd., Suite 107
    City
    Shelton
    State
    CT
    ZIP
    06484
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170539

    Owner / Operator

    Firm Name
    Zimmer Inc. / Avitus Orthopaedics Inc.
    Operator Number
    10051767
    Address
    6 Armstrong Rd., Suite 107
    City
    Shelton
    State
    CT
    Postal Code
    06484
    Country
    US
    Correspondent
    Doug Cuny

    Products

    Device Name Product Code
    Instrument, Biopsy KNW
    Syringe, Piston FMF
    Tray, Surgical, Instrument FSM
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Avitus® Bone Harvester Insert – 8mm Avitus® Bone Harvester with Filter Insert – 5mm Avitus Precision Autograft Delivery System Avitus Avitus Bone Harvester – 8mm Avitus Pilot Hole Creator 11mm x 20mm Avitus Pilot Hole Creator - 8mm x 20mm, Disposable Avitus DragonWing Large Volume Autograft Delivery System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility