BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Insert 2.5 for 4.3 Cannula

    Reg #: 1833986 · FEI: 1000139987 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PRECISION EDGE SURGICAL PRODUCTS COMPANY
    Registration Number
    1833986
    FEI Number
    1000139987
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    415 W 12th Ave
    City
    Sault Sainte Marie
    State
    MI
    ZIP
    49783
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100111

    Owner / Operator

    Firm Name
    Precision Edge Surgical Products Company
    Operator Number
    10042577
    Address
    415 West 12th Avenue
    City
    Sault Sainte Marie
    State
    MI
    Postal Code
    49783
    Country
    US
    Correspondent
    Angela Gorsuch

    Products

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

    Proprietary Names

    Insert 2.5 for 4.3 Cannula Cannula Screw 95 Deg Bit Drill 4.5 mm x 195 mm Bit Drill 3 mm x 195 mm Guide Compression Drill for 5 Screws Bit Drill 3.5 mm x 195 mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)