BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AVANTI ORTHOPAEDICS LLC

    Reg #: 3016247852 · FEI: 3016247852 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    AVANTI ORTHOPAEDICS LLC
    Registration Number
    3016247852
    FEI Number
    3016247852
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1245 Hollow Road
    City
    Penn Valley
    State
    PA
    ZIP
    19072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191118

    Owner / Operator

    Firm Name
    Avanti
    Operator Number
    10062225
    Address
    1245 Hollow Road
    City
    Penn Valley
    State
    PA
    Postal Code
    19072
    Country
    US
    Correspondent
    John D Patterson

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    Avanti Forearm Plates Avanti Cannulated Screw Avanti Wrist Fusion Plates Avanti Wrist Spanning Plates Avanti Distal Radius Plates Avanti Ulnar Plates Avanti Orthopaedics Ulnar Shortening System Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws Avanti Orthopaedics 3.2mm, and 4mm Cannulated Compression Screws

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198