BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medline UNITE® REFLEX® Hybrid Nitinol Implant System

    Reg #: 3004579081 · FEI: 3004579081 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEMRY CORPORATION
    Registration Number
    3004579081
    FEI Number
    3004579081
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Berkshire Blvd
    City
    Bethel
    State
    CT
    ZIP
    06801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243888

    Owner / Operator

    Firm Name
    Resonetics, LLC
    Operator Number
    10078190
    Address
    26 Whipple Street
    City
    Nashua
    State
    NH
    Postal Code
    03060
    Country
    US
    Correspondent
    Jamie L Vaillancourt

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Staple, Fixation, Bone JDR

    Proprietary Names

    Medline UNITE® REFLEX® Hybrid Nitinol Implant System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)