BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zplate Anterior Fixation System

    Reg #: 1824199 · FEI: 1824199 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    WARSAW ORTHOPEDIC, INC.
    Registration Number
    1824199
    FEI Number
    1824199
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2500 SILVEUS CROSSING
    City
    WARSAW
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    510(k) Number
    K991460

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    Zplate Anterior Fixation System

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device