BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Harmony Retractor System

    Reg #: 3010009693 · FEI: 3010009693 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    rms Surgical
    Registration Number
    3010009693
    FEI Number
    3010009693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1220 Lund Blvd
    City
    Anoka
    State
    MN
    ZIP
    55303
    Country
    US

    Owner / Operator

    Firm Name
    THE CRETEX COMPANIES, INC.
    Operator Number
    9001389
    Address
    311 LOWELL AVE., --
    City
    Elk River
    State
    MN
    Postal Code
    55330
    Country
    US
    Correspondent
    DARREN A KLATT

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM

    Proprietary Names

    Harmony Retractor System V2F Harmony (Surgical Port) GTS Trunnion Connection Lid CASE ASSEMBLY FULL LENGTH H100 NEXEL TOTAL ELBOW INSTRUMENT CASES ROSA® PPK MED CG AL&BR Bracket LID ASSY HALF LENGTH VPC SYSTEM - TRAY BASE CASE LID ASSY FULL LENGTH ROSA® NexGen® Knee ID Plate ROSA® PPK MED CG AR&BL Bracket ROSA® Modular Instrument Case CASE ASSEMBLY HALF LENGTH H100 ROSA® Knee General Instrument Case VPC SYSTEM - SCREW CADDY ROSA® Modular Tray Condyles Digitizer Bracket ROSA® Persona® Knee ID Plate ROSA® Pin Caddy ROSA® TKA Cut Guide Bracket ROSA® Vanguard® Knee ID Plate ROSA® PKA Validation Tool Bracket Universal Tool Assembly Bracket ROSA® Persona Partial Knee ID Plate

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)