BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INDEPENDENCE MIS

    DI: 00889095311082 · Model: 3135.1215 · GLOBUS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INDEPENDENCE MIS
    Primary DI
    00889095311082
    Version / Model
    3135.1215
    Company Name
    GLOBUS MEDICAL, INC.
    Labeler DUNS
    139105691
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-14
    Public Version
    1
    Public Version Date
    2025-07-22
    Public Version Status
    New
    Public Device Record Key
    9ba2cdac-8d1e-41f7-abaa-8f8dc81bdb56

    Device Description

    INDEPENDENCE MIS SPACER, 29 x 39mm 15°, 15mm

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MAX Intervertebral fusion device with bone graft, lumbar
    OVD Intervertebral fusion device with integrated fixation, lumbar

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00889095311082

    Premarket Submissions

    Submission Number Supplement Number
    K160597 000