BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZS 959-11 Bacfix Hook Holder Swizzle Stick

    Reg #: 1649379 · FEI: 3000718490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    154
    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

    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
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    ZS 959-11 Bacfix Hook Holder Swizzle Stick ZS 3567-20 Power Knob Rod Reducer Long Spine Smith 0355-1215 Visualif: Medium 29mm x 36mm Trial: 12mm x 15° Spine Smith 0662-1000-08 Cynch TPLIF: 8mm Detachable Trial ZS 951-2 Bacfix Ti Bone Screw implant Holder II (with T-Handle) Spine Smith 0662-1000-07 Cynch TPLIF: 7mm Detachable Trial ZS 2151-13 Socket Head Starter with Knob ZS 3367-2 Dorsal Height and Revision Tool Spine Smith 0355-1410 Visualif: Medium 29mm x 36mm Trial: 14mm x 10° Spine Smith 0662-1000-11 Cynch TPLIF: 11mm Detachable Trial ZS 1877-500 Locker-Large ZS 2151-5 Set-Screw T-Handle (7/32" Hex) Quick Release Long Shaft Spine Smith 0150-0030 Cimplicity: Kerrison Tip 17mm(W) x 14mm(D) ZS 955-6 Bacfix Cannulated Provisional Locker Spine Smith 0355-1210 Visualif: Medium 29mm x 36mm Trial: 12mm x 10° Spine Smith 0661-1000-07 Cynch: Detachable Spreader 7mm Spine Smith 0660-1000 Cynch: Detachable Spreader Handle ZS 1191-1 Pathfinder Rod Reducer 20MM ZS 2151-14 Socket Head Pencil Grip Starter ZS 973-10 Bacfix Ti Rod Popper III Spine Smith 0361-0001 Visualif: Freehand Forceps Style Driver Guide ZS 3568-4 Axis Finder ZS 963-1 Bacfix Ti Serrated Tooth Locking Clip Sizer ZS 951-11 Bacfix Ti Bone Screw Implant Holder II-Modular Spine Smith 0151-2065 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x 6.5mm(H) Spine Smith 0355-0805 Visualif: Medium 29mm x 36mm Trial: 8mm x 5° Spine Smith 0355-1405 Visualif: Medium 29mm x 36mm Trial: 14mm x 5° Spine Smith 0662-1000-14 Cynch TPLIF: 14mm Detachable Trial ZS 601-124 BacFix TI Multi-Axial Screw Implant Holder ZS 3559-3 Screw Assembly Tool Spine Smith 0151-1085 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 8.5mm(H) Spine Smith 0151-4075 Cimplicity:Parallel Trial 13mm(W) x 10mm(D) x 7.5mm(H) ZS 1904-020 Tissue Dilator #2 ZS 1868-12 Shim, 12MM ZS 1868-10 Shim, 10MM ZS 3354-1 Pedicle Sounder Curved Flexible ZS 875-2 Bacfix Parallel Distracter Spine Smith 0151-0105 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 10.5mm(H) ZS 3367-0 Sequoia Gen I Revision Tool ZS 969-20 Bacfix rod retainer Tube (for Swizzle Stick) ZS 1904-060 Tissue Dilator #6 ZS 1868-08 Shim, 08MM ZIMMER ITEM NO 6220-01-001 NKII REV A/P CHMFR BLOCK ZS 3554-100 Pedicle Access Tool Sheath Spine Smith 0151-2095 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x 9.5mm(H) ZS 1871-1 InFix Endcap Inserter ZS 1755-01 Ant-Cer Single Level Restrictor Plate Removal Driver ZS 3366-1 Screw Head Adjuster ZS 3373-1 Sequoia Power Rod Reducer Spine Smith 0151-0085 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 8.5mm(H) ZS 1904-040 Tissue Dilator #4 ZS 2162-1 All Mighty Reduction Instrument Spine Smith 0662-1000-10 Cynch TPLIF: 10mm Detachable Trial ZS 2761-1 T-Handle with J-Hook Spine Smith 0150-0130 Cimplicity: Forceps Style Cervical Implant Holder 17mm(W)x14mm(D) Spine Smith 0355-1015 Visualif: Medium 29mm x 36mm Trial: 10mm x 15° Spine Smith 0661-1000-09 Cynch: Detachable Spreader 9mm Pioneer 0252-0001 Temp Fixation Screw-Pin Inserter/Remover ZS 3551-010 Tissue Dilator A ZS 3565-1 Percutaneous Rod Pusher ZS 952-2 Multiax Scrw Implant Holder Spine Smith 0151-2085 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x8.5mm(H) ZS 1877-300 Locker-Medium ZS 2160-1 Rod Holder Gripper- Straight Tip ZS 1904-050 Tissue Dilator #5 ZS 1910-20 Extension Rod ZS 3551-020 Tissue Dilator B Spine Smith 0150-0155 Cimplicity: Shaft Style Cervical Implant Holder with Stop Spine Smith 0151-1055 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 5.5mm(H) ZS 1904-010 Tissue Dilator#1 ZS 601-031-S BacFix TI Rod Releaser (Screw Lever) Spine Smith 0151-1075 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 7.5mm(H) Spine Smith 0150-0100 Cimplicity: Forceps Style Cervical Implant Holder 13mm(W) x 10mm(D) Spine Smith 0151-0095 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 9.5mm(H) ZS 780-140 Rod Holder Spine Smith 0151-2055 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x 5.5mm(H) Spine Smith 0355-1005 Visualif: Medium 29mm x 36mm Trial: 10mm x 5° ZS 3354-2 Pedicle Sounder Straight Flexible Spine Smith 0150-0010 Cimplicity: Kerrison Style Cervical Implant Holder ZS 1868-14 Shim, 14MM ZS 2159-3 Axis Finder: T-Bar Handle Spine Smith 0150-0020 Cimplicity: Kerrison Tip 13mm(W) x 10mm(D) Spine Smith 0151-1065 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 6.5mm(H) Zimmer 1904-040, Tissue Dilator #4 Zimmer 1904-010, Tissue Dilator #1 Zimmer 1904-060, Tissue Dilator #6 Zimmer 1155-4, Cannulated T-Handle Bone Awl I ZS 7069-01 Nex-Link Oct Closed Screw Offset Connector Counter Torque Zimmer 1904-030, Tissue Dilator #3 Zimmer 1904-050, Tissue Dilator #5 Zimmer 1904-020, Tissue Dilator #2 Zimmer 7069-01, Nex-Link OCT Closed Screw Offset Connector Counter Torque ZS 871-101 Double Action Rod Gripper-Hold RSS Glenosphere Removal Handle-S DWG-04-0961-067-501 Compression Wheel DWG-04-1010-5025 Target Guide Support DWG-04-1010-5021 Driver Shaft-3.5mm Hex Screwdriver DWG-04-1010-5020 Tibial Impactor Adapter DWG-04-1020-4106 MUH Trial Collar Medium DWG-04-605-003 Talar Impactor DWG-04-1020-3098 MUH Back Table Assy Pad DWG-04-605-007 Fixation Bolt Lock Screw DWG-04-1010-5053 Insert Inserter DWG-04-1020-3007 Fin-Lock Punch DWG-04-0926-512 Talar Cut Guide - Large DWG-04-1020-3032 Tibial Impactor Stop DWG-04-1020-3108 Talar Cut Guide- Small DWG-04-1020-3031 Tissue Protector Removal Tool DWG-04-1010-5052 Nail Fixation Bolt DWG-04-1010-5010 ZS 1904-030 Tissue Dilator #3 ZS 9259-002 Pedestal Tap Straight Handle Spine Smith 0151-0065 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 6.5mm(H) Spine Smith 0151-4105 Cimplicity:Parallel Trial 13mm(W) x 10mm(D) x 10.5mm(H) ZS 497-1 SC-ACUFIX Temp Fixation Pin In ZS 871-200 Bacfix Rod Holder: 5.5mm/6mm Rods Spine Smith 0151-0055 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 5.5mm(H) Spine Smith 0151-4095 Cimplicity:Parallel Trial 13mm(W) x 10mm(D) x 9.5mm(H) ZS 1762-01 Ant-Cer Multi-Level Restrictor Plate Removal Driver ZS 2151-4 Set-Screw T-Handle (7/32" Hex) Quick Release Standard Shaft ZS 951-10 Implant Holder No Tissue Shield Thru Shaft Spine Smith 0355-1415 Visualif: Medium 29mm x 36mm Trial: 14mm x 15° Spine Smith 0662-1000-09 Cynch TPLIF: 9mm Detachable Trial Spine Smith 0662-1000-15 Cynch TPLIF: 15mm Detachable Trial Pioneer 0251-0001 Cequence Cervical Plate Holder Spine Smith 0151-4085 Cimplicity:Parallel Trial 13mm(W) x 10mm(D) x 8.5mm(H) Spine Smith 0662-1000-13 Cynch TPLIF: 13mm Detachable Trial ZS 952-1 Implant Holder Bacfix Ti, Multiaxial Screw Driver (Modular) Spine Smith 0355-0810 Visualif: Medium 29mm x 36mm Trial: 8mm x 10° Spine Smith 0661-1000-11 Cynch: Detachable Spreader 11mm Pioneer 0262-1001 Cequence, Counter Torque Wrench II ZS 479-1 SC-ACUFIX Threaded Screw Removal Driver Spine Smith 0355-0815 Visualif: Medium 29mm x 36mm Trial: 8mm x 15° Spine Smith 0662-1000-12 Cynch TPLIF: 12mm Detachable Trial ZS 3567-10 Power Knob Rod Reducer Short Spine Smith 0151-2105 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x 10.5mm(H) ZS 7058-01 Nex-Link Oct Occipital Rod Reduction Forceps ZS 3573-10 Fixed Percutaneous Rod Holder Spine Smith 0151-4055 Cimplicity: Parallel Trial 13mm(W) x 10mm(D) x 5.5mm(H) Spine Smith 0355-1205 Visualif: Medium 29mm x 36mm Trial: 12mm x 5° Spine Smith 0151-2075 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x 7.5mm(H) Spine Smith 0355-1010 Visualif: Medium 29mm x 36mm Trial: 10mm x 10° ZS 1877-100 Locker-Small ZS 3560-1 Tissue Dilation Wedge ZS 1852-2 InFix Strut Remover ZS 601-044 BacFix TI Large OD Flexible Angle Implante Holder- Fixed T-Handle ZS 1911-19-1140 Radiolucent Dilator #4 (19MM X 1 ZS 3354-3 Pedicle Sounder Straight Stiff Spine Smith 0151-1095 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 9.5mm(H) Spine Smith 0151-4065 Cimplicity:Parallel Trial 13mm(W) x 10mm(D) x 6.5mm(H) ZS 3382-1 Sequoia Counter Torque Tube ZS 3551-300 Tissue Dilator C, Radiolucent Spine Smith 0150-0150 Cimplicity: Shaft Style Cervical Implant Holder Spine Smith 0151-1105 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 10.5mm(H) Spine Smith 0151-0075 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 7.5mm(H)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)