BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lever Action Plate System

    Reg #: 3011569539 · FEI: 3011569539 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MCGINLEY ORTHOPAEDIC INNOVATIONS, INC
    Registration Number
    3011569539
    FEI Number
    3011569539
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    234 E. 1st Street, Ste 242
    City
    Casper
    State
    WY
    ZIP
    82601
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200834

    Owner / Operator

    Firm Name
    McGinley Orthopaedic Innovations, INC
    Operator Number
    10048881
    Address
    234 E 1st Street, Suite 242
    City
    Casper
    State
    WY
    Postal Code
    82601
    Country
    US

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS

    Proprietary Names

    Lever Action Plate System

    Establishment Types

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