BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Kinetic-SL Dynamic Anterior Cervical Plate System

    DI: 00190837037031 · Model: 113-959-1 · Life Spine, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Kinetic-SL Dynamic Anterior Cervical Plate System
    Primary DI
    00190837037031
    Version / Model
    113-959-1
    Catalog Number
    113-959-1
    Company Name
    Life Spine, Inc.
    Labeler DUNS
    183641617
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-07
    Public Version
    2
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    fb4ad127-2080-4e03-b341-3cb1cffb0e52

    Device Description

    Level Drill Guide Attachment

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    KWQ Appliance, fixation, spinal intervertebral body

    GMDN Terms

    Code Name
    46653 Spinal fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 00190837037031

    Premarket Submissions

    Submission Number Supplement Number
    K073479 000