BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZEVO™ Anterior Cervical Plate System

    DI: 00763000663414 · Model: 3001021 · MEDTRONIC SOFAMOR DANEK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ZEVO™ Anterior Cervical Plate System
    Primary DI
    00763000663414
    Version / Model
    3001021
    Company Name
    MEDTRONIC SOFAMOR DANEK, INC.
    Labeler DUNS
    830350380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-01
    Public Version
    2
    Public Version Date
    2025-11-20
    Public Version Status
    Update
    Public Device Record Key
    319e8c03-b3de-4a64-a4ac-f6ffb6e21cc4

    Device Description

    PLATE 3001021 ZEVO 21MM 1 LVL

    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 00763000663414

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K141632 000