BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CM TAPER REAMER 15.5 MM

    Reg #: 1833986 · FEI: 1000139987 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    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
    K091566

    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
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    CM TAPER REAMER 15.5 MM LONG CM LAG SCREW REAMER CM LAG SCREW REAMER 3.2MM ID LONG CM LAG SCW PIN CANN 3.2MM CM INNER CHANNEL REAMER CM LAG SCREW TAP 3.2MM ID INNER CHANNEL REAMER SLEEVE LONG CM LAG SCREW TAP SHORT CM LAG SCREW INSERTER CM CHANNEL REAMER SLV 15.5MM LONG CM LAG SCREW INSERTER CM SCREWDRIVER 3.5MM HEX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)