BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Revolution External Plating System

    Reg #: 3015536247 · FEI: 3015536247 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NEW STANDARD DEVICE INC.
    Registration Number
    3015536247
    FEI Number
    3015536247
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4600 Lockhill Selma Road Suite107
    City
    San Antonio
    State
    TX
    ZIP
    78249
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233025

    Owner / Operator

    Firm Name
    Fusion Orthopedics, LLC.
    Operator Number
    10053147
    Address
    4135 S Power Rd., Suite 110
    City
    Mesa
    State
    AZ
    Postal Code
    85212
    Country
    US
    Correspondent
    Adam Cundiff

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    Revolution External Plating System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198