BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Stable-L™

    DI: B6785250870 · Model: 525087 · NEXUS SPINE, L.L.C.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Stable-L™
    Primary DI
    B6785250870
    Version / Model
    525087
    Company Name
    NEXUS SPINE, L.L.C.
    Labeler DUNS
    028137605
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-30
    Public Version
    2
    Public Version Date
    2023-06-09
    Public Version Status
    Update
    Public Device Record Key
    8376f7eb-10e9-4b3e-ab05-f70ba72aec05

    Device Description

    Stable-L Interbody 36x28x10, 6 Deg

    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
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    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 B6785250870

    Premarket Submissions

    Submission Number Supplement Number
    K212498 000

    Device Sizes

    Type Value Unit Text
    Height 10 Millimeter
    Width 36 Millimeter
    Length 28 Millimeter