BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spine Smith 0302-1420 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 20°

    Reg #: 1649379 · FEI: 3000718490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BANISTER TOOL, INC.
    Registration Number
    1649379
    FEI Number
    3000718490
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3009 A W Grimes Blvd
    City
    Pflugerville
    State
    TX
    ZIP
    78660
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102090

    Owner / Operator

    Firm Name
    Banister Tool, Inc.
    Operator Number
    10042616
    Address
    3009 A W Grimes Blvd
    City
    Pflugerville
    State
    TX
    Postal Code
    78660
    Country
    US
    Correspondent
    Burke Ramsay

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Proprietary Names

    Spine Smith 0302-1420 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 20° Spine Smith 0302-1220 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 20° Spine Smith 0303-1220 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 20° Spine Smith 0306-5528 VisuALIF: 5.5mm x 28mm Constrained Bone Screw Spine Smith 0301-1420 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 20° Spine Smith 0302-1015 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 15° Spine Smith 0301-1010 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 10° Spine Smith 0301-1015 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 15° Spine Smith 0302-1205 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 5° Spine Smith 0301-0810 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 10° Spine Smith 0301-0820 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 20° Spine Smith 0303-1010 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 10° Spine Smith 0303-0810 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 10° Spine Smith 0301-1205 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 5° Spine Smith 0303-1015 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 15° Spine Smith 0302-0810 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 10° Spine Smith 0303-1005 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 5° Spine Smith 0302-1210 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 10° Spine Smith 0302-0805 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 5° Spine Smith 0303-0815 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 15° Spine Smith 0301-0815 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 15° Spine Smith 0303-1020 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 20° Spine Smith 0302-1410 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 10° Spine Smith 0301-1215 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 15° Spine Smith 0301-1415 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 15° Spine Smith 0302-0820 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 20° Spine Smith 0302-1215 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 15° Spine Smith 0303-0820 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 20° Spine Smith 0301-1005 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 5° Spine Smith 0303-1215 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 15° Spine Smith 0302-1020 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 20° Spine Smith 0302-1415 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 15° Spine Smith 0301-1405 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 5° Spine Smith 0306-5523 VisuALIF: 5.5mm x 23mm Constrained Bone Screw Spine Smith 0302-0815 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 15° Spine Smith 0303-1410 VisuALIF: Large 29mm x 42mm PEEK Implant: 14mm x 10° Spine Smith 0301-1210 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 10° Spine Smith 0301-1220 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 20° Spine Smith 0302-1405 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 5° Spine Smith 0301-0805 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 5° Spine Smith 0302-1005 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 5° Spine Smith 0306-5525 VisuALIF: 5.5mm x 25mm Constrained Bone Screw Spine Smith 0301-1020 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 20° Spine Smith 0303-0805 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 5° Spine Smith 0303-1405 VisuALIF: Large 29mm x 42mm PEEK Implant: 14mm x 5° Spine Smith 0301-1410 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 10° Spine Smith 0306-5533 VisuALIF: 5.5mm x 33mm Constrained Bone Screw Spine Smith 0303-1205 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 5° Spine Smith 0302-1010 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 10° Spine Smith 0303-1415 VisuALIF: Large 29mm x 42mm PEEK Implant: 14mm x 15° Spine Smith 0303-1210 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 10°

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)