BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IO™ Expandable Lumbar Interbody System

    DI: 00810025487706 · Model: 6-1022-L · MIRUS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IO™ Expandable Lumbar Interbody System
    Primary DI
    00810025487706
    Version / Model
    6-1022-L
    Company Name
    MIRUS LLC
    Labeler DUNS
    080311078
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-27
    Public Version
    1
    Public Version Date
    2023-02-06
    Public Version Status
    New
    Public Device Record Key
    cf602058-5cd0-4182-93e4-6150a741b0c0

    Device Description

    IO™ Expandable Lumbar Interbody, 10mm X 22mm, LORDOTIC

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00810025487706

    Premarket Submissions

    Submission Number Supplement Number
    K210800 000