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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Leva® Anterior Expandable Spacer System

    DI: 10840642109337 · Model: 11-0785 · Spine Wave, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Leva® Anterior Expandable Spacer System
    Primary DI
    10840642109337
    Version / Model
    11-0785
    Catalog Number
    11-0785
    Company Name
    Spine Wave, Inc.
    Labeler DUNS
    067789763
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-30
    Public Version
    4
    Public Version Date
    2020-02-24
    Public Version Status
    Update
    Public Device Record Key
    cac3547b-b1b3-4710-aa40-44dcbbfe2f45

    Device Description

    Spacer, 38 mm (W) x 30 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion

    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 10840642109337

    Premarket Submissions

    Submission Number Supplement Number
    K163246 000