BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    V3™ Segmental Plating System

    DI: M68111210100130 · Model: 1121-01-0013 · ATLAS SPINE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    V3™ Segmental Plating System
    Primary DI
    M68111210100130
    Version / Model
    1121-01-0013
    Catalog Number
    1121-01-0013
    Company Name
    ATLAS SPINE, INC.
    Labeler DUNS
    140801007
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-23
    Public Version
    2
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    835d1a87-3c9f-4d6b-92d0-0b4382d0c5aa

    Device Description

    13mm Plate Assembly

    Device Characteristics

    Single Use
    Yes
    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
    MR Conditional
    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 M68111210100130

    Premarket Submissions

    Submission Number Supplement Number
    K182418 000

    Device Sizes

    Type Value Unit Text
    Length 13 Millimeter