BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spinal Jaxx Interbody Fusion Device

    DI: 00818956020573 · Model: 100001-370 · NEUROPRO SPINAL JAXX INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Spinal Jaxx Interbody Fusion Device
    Primary DI
    00818956020573
    Version / Model
    100001-370
    Catalog Number
    100001-370
    Company Name
    NEUROPRO SPINAL JAXX INC.
    Labeler DUNS
    080554344
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    12aec7a1-0156-46c4-a4ab-335034d60eae

    Device Description

    Implant Graft Delivery, 21 mm & 25 mm

    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
    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

    GMDN Terms

    Code Name
    46119 Bone graft delivery kit

    Identifiers

    Type ID
    Primary 00818956020573

    Customer Contacts

    Phone
    209-545-5111
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K152501 000