BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DRILL BIT, SOLID CORE, 1.3MM

    Reg #: 3026576110 · FEI: 3026576110 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Precision Edge Surgical Products, LLC
    Registration Number
    3026576110
    FEI Number
    3026576110
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1910 N. Wayne Street
    City
    Angola
    State
    IN
    ZIP
    46703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181820

    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
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    DRILL BIT, SOLID CORE, 1.3MM DRILL BIT, SOLID CORE, 1.9MM DRILL BIT, SOLID CORE, 1.6MM DRILL BIT,STAPLE,AO/QC,1.8MM DRILL BIT, STAPLE,LONG 2MM DRILL BIT,STAPLE,AO/QC, 1.6MM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)