BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Certex Spinal Implant System - XSpine

    Reg #: 1835251 · FEI: 3000205591 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NGInstruments, Inc dba Avalign Cutting Instruments
    Registration Number
    1835251
    FEI Number
    3000205591
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4643 N State Road 15
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122163

    Owner / Operator

    Firm Name
    NG Instruments, Inc dba Avalign Cutting Instruments
    Operator Number
    10042855
    Address
    4643 North State Road 15
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US
    Correspondent
    Heidi Funston

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    Certex Spinal Implant System - XSpine

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)