BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Axle-X spinous fusion system

    Reg #: 3030708794 · FEI: 3030708794 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SUMMIT CITY PRECISION MACHINE
    Registration Number
    3030708794
    FEI Number
    3030708794
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    815 Lawrence Drive
    City
    Fort Wayne
    State
    IN
    ZIP
    46804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130438

    Owner / Operator

    Firm Name
    Summit City Precision Machine
    Operator Number
    10090434
    Address
    815 Lawrence Drive
    City
    Fort Wayne
    State
    IN
    Postal Code
    46804
    Country
    US
    Correspondent
    Nick A Acra

    Products

    Device Name Product Code
    Spinous Process Plate PEK

    Proprietary Names

    Axle-X spinous fusion system

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)