BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACDF Stand Alone Cervical

    DI: 07630040726191 · Model: 03.18.417 · Medacta International SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACDF Stand Alone Cervical
    Primary DI
    07630040726191
    Version / Model
    03.18.417
    Company Name
    Medacta International SA
    Labeler DUNS
    488227125
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-26
    Public Version
    1
    Public Version Date
    2020-07-06
    Public Version Status
    New
    Public Device Record Key
    389a2912-bff4-46ce-bf34-1f61a473e187

    Device Description

    Mecta-C SA – Plate Quattro Lag h7

    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 07630040726191

    Premarket Submissions

    Submission Number Supplement Number
    K192906 000