BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StaXx(R) XD System

    Reg #: 3004638600 · FEI: 3004638600 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SPINE WAVE, INC.
    Registration Number
    3004638600
    FEI Number
    3004638600
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    THREE ENTERPRISE DR., SUITE 210
    City
    SHELTON
    State
    CT
    ZIP
    06484
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101288

    Owner / Operator

    Firm Name
    SPINE WAVE, INC.
    Operator Number
    9055730
    Address
    THREE ENTERPRISE DR., SUITE 210
    City
    Shelton
    State
    CT
    Postal Code
    06484
    Country
    US
    Correspondent
    RONALD K SMITH

    Products

    Device Name Product Code
    Spinal Vertebral Body Replacement Device MQP

    Proprietary Names

    StaXx(R) XD System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device