BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    True Tulip Spinal Fixation System

    DI: B50620593085451 · Model: 205-9-308-545 · INNOVATIVE SURGICAL DESIGNS
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    True Tulip Spinal Fixation System
    Primary DI
    B50620593085451
    Version / Model
    205-9-308-545
    Company Name
    INNOVATIVE SURGICAL DESIGNS
    Labeler DUNS
    078306079
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-11
    Public Version
    2
    Public Version Date
    2021-01-04
    Public Version Status
    Update
    Public Device Record Key
    c422216a-4cbe-419b-a941-29fb3b2e9729

    Device Description

    5.5 mm x 45 mm True MIS Pedicle Screw

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    NKB Thoracolumbosacral Pedicle Screw System
    KWP Appliance, Fixation, Spinal Interlaminal

    GMDN Terms

    Code Name
    61324 Bone-screw internal spinal fixation system, sterile

    Identifiers

    Type ID
    Primary B50620593085451