BEUDAMED
    FDA Registration Active 🇺🇸 United States

    A’TOMIC™ Nitinol Fixation System

    Reg #: 3031160399 · FEI: 3031160399 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    RMR ORTHO, LLC
    Registration Number
    3031160399
    FEI Number
    3031160399
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4600 Lockhill Selma Road Suite 107
    City
    San Antonio
    State
    TX
    ZIP
    78249
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232990

    Owner / Operator

    Firm Name
    RMR Ortho, LLC
    Operator Number
    10090810
    Address
    4600 Lockhill Selma Road Suite 107
    City
    San Antonio
    State
    TX
    Postal Code
    78249
    Country
    US
    Correspondent
    Monica Lesch

    Products

    Device Name Product Code
    Staple, Fixation, Bone JDR

    Proprietary Names

    A’TOMIC™ Nitinol Fixation System

    Establishment Types

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