BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OptiMesh Multiplanar Expandable Interbody Fusion System

    DI: M7403010156 · Model: 10-01-100 · SPINEOLOGY INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OptiMesh Multiplanar Expandable Interbody Fusion System
    Primary DI
    M7403010156
    Version / Model
    10-01-100
    Catalog Number
    301-0156
    Company Name
    SPINEOLOGY INC.
    Labeler DUNS
    033014361
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-14
    Public Version
    1
    Public Version Date
    2023-09-22
    Public Version Status
    New
    Public Device Record Key
    a6a1734c-9db5-405f-a5eb-4c8b8d9ded74

    Device Description

    Spineology Jackson Table Rail/Bracket

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    62379 Surgical instrument assist arm system, manually-adjusted

    Identifiers

    Type ID
    Primary M7403010156

    Customer Contacts

    Phone
    651-256-8500
    Email
    [email protected]