BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RESELUTE

    Reg #: 3042025564 · FEI: 3042025564 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    RESELUTE
    Registration Number
    3042025564
    FEI Number
    3042025564
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    701 W Main Street, Ste 420
    City
    Durham
    State
    NC
    ZIP
    27701
    Country
    US

    Owner / Operator

    Firm Name
    Reselute
    Operator Number
    10094154
    Address
    906 Arnette Ave
    City
    Durham
    State
    NC
    Postal Code
    27701
    Country
    US
    Correspondent
    Cambre Kelly

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Reselute Tibial Intramedullary Instrument Tray

    Establishment Types

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