Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1649379

FEI Number

3000718490

Entity Name

BANISTER TOOL, INC.

City/State/Country

Pflugerville, TX, US

Establishment Address

3009 A W Grimes Blvd, Pflugerville, TX 78660, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Banister Tool, Inc. (Owner Number: 10042616)

Owner / Operator Contact Address

3009 A W Grimes Blvd, Pflugerville, TX 78660, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZS 810-300 Intra-Sacral 1/4" SS Rod - 300mm ZS 810-450 Intra-Sacral 1/4" SS Rod - 450mm ZS 810-075 Intra-Sacral 1/4" SS Rod - 75mm ZS 810-125 Intra-Sacral 1/4" SS Rod - 125mm ZS 810-050 Intra-Sacral 1/4" SS rod - 50mm ZS 810-100 Intra-Sacral 1/4" SS Rod - 100mm Peripheral Reamer Eccentric MOD DWG-0960-076-502 RSS Baseplate Peripheral Reamer, Concentric-S DWG-04-0961-076-501 Peripheral Reamer Concentric MOD DWG-0960-076-501 RSS Baseplate Peripheral Reamer, Eccentric-S DWG-04-0961-075-501 Ascension Orthopedics Rod, Fixation, Intramedullary and Accessories ZS 3552-250 Cannulated Drill-Awl-Tap 5MM ZS 3554-040 Pedicle Access Tool Tap 4MM ZS 3360-055 Sequoia Bone Tap with Color Sleeve 5.5MM ZS 3360-075 Sequoia Bone Tap with Color Sleeve 7.5MM ZS 3552-260 Cannulated Drill-Awl-Tap 6MM ZS 3552-140 Cannulated Awl-Tap 4MM ZS 3552-170 Cannulated Awl-Tap 7MM ZS 3360-065 Sequoia Bone Tap with Color Sleeve 6.5MM ZS 3554-070 Pedicle Access Tool Tap 7MM ZS 3552-150 Cannulated Awl-Tap 5MM ZS 3554-060 Pedicle Access Tool Tap 6MM ZS 3552-270 Cannulated Drill-Awl-Tap 7MM ZS 3360-045 Sequoia Bone Tap with Color Sleeve 4.5MM ZS 3554-050 Pedicle Access Tool Tap 5MM ZS 3552-160 Cannulated Awl-Tap 6MM ZS 3552-240 Cannulated Drill-Awl-Tap 4mm ZS 3360-040 Sequoia Bone Tap with Color Sleeve 4MM ZS 2662-1 Tamp Tip Ascension, Finger, Semi-constrained pyrolitic cartom uncemented prosthesis Pioneer PN 0255-0010, Cequence, Fixed Handle Bone Awl ZS, PN 3350-1, Bone Awl Spine Smith 0302-1405 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 5° Spine Smith 0303-1015 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 15° Spine Smith 0302-1015 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 15° Spine Smith 0301-1215 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 15° Spine Smith 0303-1410 VisuALIF: Large 29mm x 42mm PEEK Implant: 14mm x 10° Spine Smith 0302-1205 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 5° Spine Smith 0301-1420 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 20° Spine Smith 0301-1415 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 15° Spine Smith 0302-0805 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 5° Spine Smith 0301-1410 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 10° Spine Smith 0303-0810 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 10° 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 0302-1215 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 0302-1410 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 10° Spine Smith 0303-1205 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 5° Spine Smith 0303-1220 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 20° Spine Smith 0302-1020 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 20° Spine Smith 0302-1005 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 5° Spine Smith 0306-5523 VisuALIF: 5.5mm x 23mm Constrained Bone Screw Spine Smith 0302-1220 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 20° Spine Smith 0306-5533 VisuALIF: 5.5mm x 33mm Constrained Bone Screw Spine Smith 0302-1210 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 10° Spine Smith 0302-0820 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 20° Spine Smith 0306-5528 VisuALIF: 5.5mm x 28mm Constrained Bone Screw Spine Smith 0301-1020 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 20° Spine Smith 0301-1405 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 5° Spine Smith 0302-1010 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 10° Spine Smith 0306-5525 VisuALIF: 5.5mm x 25mm Constrained Bone Screw Spine Smith 0301-0805 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 5° 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° Spine Smith 0301-0820 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 20° Spine Smith 0302-1420 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 20° Spine Smith 0303-1010 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 10° Spine Smith 0301-1210 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 10° Spine Smith 0303-0815 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 15° Spine Smith 0302-1415 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 15° Spine Smith 0303-1005 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 5° Spine Smith 0301-1220 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 20° Spine Smith 0303-0805 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 5° Spine Smith 0301-0810 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 10° Spine Smith 0303-1020 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 20° Spine Smith 0301-1205 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 5° Spine Smith 0301-0815 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 15° Spine Smith 0302-0815 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 15° Spine Smith 0301-1010 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 10° Spine Smith 0302-0810 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 10° Spine Smith 0301-1015 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 15° Spine Smith 0303-1405 VisuALIF: Large 29mm x 42mm PEEK Implant: 14mm x 5° ZS 2106-7560 5.5mm Fixed Angle Screw-Closed 7 ZS 2106-6530 5.5mm Fixed Angle Screw-Closed 6 ZS 2203-6555 1/4" SS Fixed Angle Screw Open 6.5 x 55 ZS 2206-5545 1/4" SS Fixed Angle Screw Closed 5.5 x 45 ZS 2206-8540 1/4" SS Fixed Angle Screw Closed 8.5 x 40 ZS 2106-5525 5.5mm Fixed Angle Screw-Closed 5 ZS 2106-7535 5.5mm Fixed Angle Screw-Closed 7 ZS 2202-111 1/4" SS Offset Connector Clsd ZS 601-025-7530 PARS Defect Screw III Closed Cannulated 7.5x30 ZS 2106-7555 5.5mm Fixed Angle Screw-Closed 7 ZS 2204-11N-SB 1/4" SS Narrow Standard Body Hook Open ZS 2206-5535 1/4" SS Fixed Angle Screw Closed 5.5 x 35 ZS 2106-6545 5.5mm Fixed Angle Screw-Closed 6 ZS 2106-7590 5.5mm Fixed Angle Screw-Closed 7 ZS 2203-4535 1/4" SS Fixed Angle Screw Open 4.5 x 35 ZS 2206-7540 1/4" SS Fixed Angle Screw Closed 7.5 x 40 ZS 2102-175 5.5mm TI Offset Connector Closed 7.5mm ZS 2106-8535 5.5mm Fixed Angle Screw-Closed 8 ZS 2204-7N-SB 1/4" SS Narrow Standard Body Hook Open ZS 2106-7540 5.5mm Fixed Angle Screw-Closed 7 ZS 2106-8580 5.5mm Fixed Angle Screw-Closed 8 ZS 2203-5545 1/4" SS Fixed Angle Screw Open 5.5 x 45 ZS 2206-6540 1/4" SS Fixed Angle Screw Closed 6.5 x 40 ZS 2106-6540 5.5mm Fixed Angle Screw-Closed 6 ZS 2203-7560 1/4" SS Fixed Angle Screw Open 7.5 x 60 ZS 2206-8570 1/4" SS Fixed Angle Screw Closed 8.5 x 70 ZS 2206-7555 1/4" SS Fixed Angle Screw Closed 7.5 x 55 ZS 2203-5525 1/4" SS Fixed Angle Screw Open 5.5 x 25 ZS 2206-7560 1/4" SS Fixed Angle Screw Closed 7.5 x 60 ZS 2203-7535 1/4" SS Fixed Angle Screw Open 7.5 x 35 ZS 2203-6545 1/4" SS Fixed Angle Screw Open 6.5 x 45 ZS 2206-7550 1/4" SS Fixed Angle Screw Closed 7.5 x 50 ZS 2206-8580 1/4" SS Fixed Angle Screw Closed 8.5 x 80 ZS 2203-8535 1/4" SS Fixed Angle Screw Open 8.5 x 35 ZS 2204-9N-SB 1/4" SS Narrow Standard Body Hook Open ZS 2206-7580 1/4" SS Fixed Angle Screw Closed 7.5 x 80 ZS 2203-8540 1/4" SS Fixed Angle Screw Open 8.5 x 40 ZS 2203-8590 1/4" SS Fixed Angle Screw Open 8.5 x 90 ZS 2203-7590 1/4" SS Fixed Angle Screw Open 7.5 x 90 ZS 2206-7590 1/4" SS Fixed Angle Screw Closed 7.5 x 90 ZS 2106-8570 5.5mm Fixed Angle Screw-Closed 8 ZS 2203-5540 1/4" SS Fixed Angle Screw Open 5.5 x 40 ZS 2204-9N-EB 1/4" SS Narrow Extended Body Hook Open ZS 2106-8590 5.5mm Fixed Angle Screw-Closed 8 ZS 2203-7545 1/4" SS Fixed Angle Screw Open 7.5 x 45 ZS 2206-6550 1/4" SS Fixed Angle Screw Closed 6.5 x 50 ZS 2106-4530 5.5mm Fixed Angle Screw-Closed 4 ZS 2106-7530 5.5mm Fixed Angle Screw-Closed 7 ZS 2202-130 1/4" SS Offset Connector Clsd ZS 2203-7540 1/4" SS Fixed Angle Screw Open 7.5 x 40 ZS 2203-7580 1/4" SS Fixed Angle Screw Open 7.5 x 80 ZS 2206-4535 1/4" SS Fixed Angle Screw Closed 4.5 x 35 ZS 2106-7570 5.5mm Fixed Angle Screw-Closed 7 ZS 2203-6550 1/4" SS Fixed Angle Screw Open 6.5 x 50 ZS 2203-7570 1/4" SS Fixed Angle Screw Open 7.5 x 70 ZS 2206-4525 1/4" SS Fixed Angle Screw Closed 4.5 x 25 ZS 2203-4525 1/4" SS Fixed Angle Screw Open 4.5 x 25 ZS 2203-4540 1/4" SS Fixed Angle Screw Open 4.5 x 40 ZS 2206-8530 1/4" SS Fixed Angle Screw Closed 8.5 x 30 ZS 2106-7545 5.5mm Fixed Angle Screw-Closed 7 ZS 2106-5540 5.5mm Fixed Angle Screw-Closed 5 ZS 2203-5535 1/4" SS Fixed Angle Screw Open 5.5 x 35 ZS 2206-6535 1/4" SS Fixed Angle Screw Closed 6.5 x 35 ZS 2206-8535 1/4" SS Fixed Angle Screw Closed 8.5 x 35 ZS 2106-5545 5.5mm Fixed Angle Screw-Closed 5 ZS 2203-6540 1/4" SS Fixed Angle Screw Open 6.5 x 40 ZS 2203-8530 1/4" SS Fixed Angle Screw Open 8.5 x 30 ZS 2206-5540 1/4" SS Fixed Angle Screw Closed 5.5 x 40 ZS 601-025-6545 PARS Defect Screw III Closed Cannulated 6.5x45 ZS 2106-7550 5.5mm Fixed Angle Screw-Closed 7 ZS 2106-6535 5.5mm Fixed Angle Screw-Closed 6 ZS 2203-8580 1/4" SS Fixed Angle Screw Open 8.5 x 80 ZS 2206-5530 1/4" SS Fixed Angle Screw Closed 5.5 x 30 ZS 2106-6555 5.5mm Fixed Angle Screw-Closed 6 ZS 2202-13 1/4" SS Offset Connector Open ZS 2206-6530 1/4" SS Fixed Angle Screw Closed 6.5 x 30 ZS 2206-7535 1/4" SS Fixed Angle Screw Closed 7.5 x 35 ZS 2106-4540 5.5mm Fixed Angle Screw-Closed 4 ZS 2106-5530 5.5mm Fixed Angle Screw-Closed 5 ZS 2202-95 1/4" SS Offset Connector Open ZS 2206-7545 1/4" SS Fixed Angle Screw Closed 7.5 x 45 ZS 2102-130 5.5mm TI Offset Connector Closed 30mm ZS 2106-6525 5.5mm Fixed Angle Screw-Closed 6 ZS 2202-30 1/4" SS Offset Connector Open ZS 2206-6555 1/4" SS Fixed Angle Screw Closed 6.5 x 55 ZS 2206-4540 1/4" SS Fixed Angle Screw Closed 4.5 x 40 ZS 2102-111 5.5mm TI Offset Connector Closed 11mm ZS 2202-175 1/4" SS Offset Connector Clsd ZS 2204-UL-SB 1/4" SS UP Lumbar Hook Standard Body ZS 2206-6545 1/4" SS Fixed Angle Screw Closed 6.5 x 45 ZS 2106-7580 5.5mm Fixed Angle Screw-Closed 7 ZS 2203-7530 1/4" SS Fixed Angle Screw Open 7.5 x 30 ZS 2203-7555 1/4" SS Fixed Angle Screw Open 7.5 x 55 ZS 2206-8590 1/4" SS Fixed Angle Screw Closed 8.5 x 90 ZS 2206-4530 1/4" SS Fixed Angle Screw Closed 4.5 x 30 ZS 2204-9W-SB 1/4" SS Wide Standard Body Hook Open ZS 2206-5525 1/4" SS Fixed Angle Screw Closed 5.5 x 25 ZS 2203-8545 1/4" SS Fixed Angle Screw Open 8.5 x 45 ZS 2206-6525 1/4" SS Fixed Angle Screw Closed 6.5 x 25 ZS 2106-8530 5.5mm Fixed Angle Screw-Closed 8 ZS 2203-5530 1/4" SS Fixed Angle Screw Open 5.5 x 30 ZS 2206-7570 1/4" SS Fixed Angle Screw Closed 7.5 x 70 ZS 2106-4535 5.5mm Fixed Angle Screw-Closed 4 ZS 2204-9W-EB 1/4" SS Wide Extended Body Hook Open ZS 2106-5535 5.5mm Fixed Angle Screw-Closed 5 ZS 2203-7550 1/4" SS Fixed Angle Screw Open 7.5 x 50 ZS 2203-6525 1/4" SS Fixed Angle Screw Open 6.5 x 25 ZS 2206-7530 1/4" SS Fixed Angle Screw Closed 7.5 x 30 ZS 2106-8545 5.5mm Fixed Angle Screw-Closed 8 ZS 2203-6530 1/4" SS Fixed Angle Screw Open 6.5 x 30 ZS 2204-11N-EB 1/4" SS Narrow Extended Body Hook Open ZS 2106-8540 5.5mm Fixed Angle Screw-Closed 8 ZS 2203-8570 1/4" SS Fixed Angle Screw Open 8.5 x 70 ZS 2204-P85-SB 1/4" SS PED Hook Standard Body Open ZS 601-025-6545-S PARS Defect Screw III Partial Thread 6.5x45 ZS 2106-6550 5.5mm Fixed Angle Screw-Closed 6 ZS 2203-4530 1/4" SS Fixed Angle Screw Open 4.5 x 30 ZS 2204-11W-SB 1/4" SS Wide Standard Body Hook Open ZS 2206-8545 1/4" SS Fixed Angle Screw Closed 8.5 x 45 ZS 2106-4525 5.5mm Fixed Angle Screw-Closed 4 ZS 2203-6535 1/4" SS Fixed Angle Screw Open 6.5 x 35 Spine Smith 0152-0075 Cimplicity: Lordotic Rasp 13mm(W) x 10mm(D) x 7.5mm(H) Spine Smith 0152-1065 Cimplicity: Lordotic Rasp w/stop 13mm(W) x 10mm(D) x 6.5mm(H) Spine Smith 0152-0065 Cimplicity: Lordotic Rasp 13mm(W) x 10mm(D) x 6.5mm(H) Spine Smith 0153-1001 Cimplicity: Implant Pusher w/stop Spine Smith 0152-1085 Cimplicity: Lordotic Rasp w/stop 13mm(W) x 10mm(D) x 8.5mm(H) Spine Smith 0152-4095 Cimplicity: Parallel Rasp 13mm(W) x 10mm(D) x 9.5mm(H) Spine Smith 0152-1095 Cimplicity: Lordotic Rasp w/stop 13mm(W) x 10mm(D) x 9.5mm(H) Spine Smith 0152-4075 Cimplicity: Parallel Rasp 13mm(W) x 10mm(D) x 7.5mm(H) Spine Smith 0152-4105 Cimplicity: Parallel Rasp 13mm(W) x 10mm(D) x 10.5mm(H) Spine Smith 0152-1055 Cimplicity: Lordotic Rasp w/stop 13mm(W) x 10mm(D) x 5.5mm(H) Spine Smith 0152-4055 Cimplicity: Parallel Rasp 13mm(W) x 10mm(D) x 5.5mm(H) Spine Smith 0152-0105 Cimplicity: Lordotic Rasp 13mm(W) x 10mm(D) x 10.5mm(H) Spine Smith 0152-0055 Cimplicity: Lordotic Rasp 13mm(W) X 10mm (D) X 5.5mm(H) Spine Smith 0152-1075 Cimplicity: Lordotic Rasp w/stop 13mm(W) x 10mm(D) x 7.5mm(H) Spine Smith 0152-0085 Cimplicity: Lordotic Rasp 13mm(W) x 10mm(D) x 8.5mm(H) Spine Smith 0152-0095 Cimplicity: Lordotic Rasp 13mm(W) x 10mm(D) x 9.5mm(H) Spine Smith 0152-4085 Cimplicity: Parallel Rasp 13mm(W) x 10mm(D) x 8.5mm(H) Spine Smith 0153-0001 Cimplicity: Implant Pusher Spine Smith 0152-4065 Cimplicity: Parallel Rasp 13mm(W) x 10mm(D) x 6.5mm(H) Spine Smith 0152-1105 Cimplicity: Lordotic Rasp w/stop 13mm(W) x 10mm(D) x 10.5mm(H) ZS 906-2 BacFix TI Washer, Flat- 2MM ZS 906-4 BacFix TI Washer, Flat -4MM ZS 3551-300 Tissue Dilator C, Radiolucent 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 Spine Smith 0150-0020 Cimplicity: Kerrison Tip 13mm(W) x 10mm(D) Spine Smith 0355-1215 Visualif: Medium 29mm x 36mm Trial: 12mm x 15° Spine Smith 0662-1000-10 Cynch TPLIF: 10mm Detachable Trial ZS 1877-100 Locker-Small Spine Smith 0150-0155 Cimplicity: Shaft Style Cervical Implant Holder with Stop Spine Smith 0361-0001 Visualif: Freehand Forceps Style Driver Guide ZS 1904-050 Tissue Dilator #5 ZS 1910-20 Extension Rod ZS 3367-0 Sequoia Gen I Revision Tool ZS 3382-1 Sequoia Counter Torque Tube ZS 780-140 Rod Holder Spine Smith 0151-4095 Cimplicity:Parallel Trial 13mm(W) x 10mm(D) x 9.5mm(H) Spine Smith 0661-1000-11 Cynch: Detachable Spreader 11mm ZS 479-1 SC-ACUFIX Threaded Screw Removal Driver ZS 3568-4 Axis Finder ZS 959-11 Bacfix Hook Holder Swizzle Stick Spine Smith 0355-1205 Visualif: Medium 29mm x 36mm Trial: 12mm x 5° Spine Smith 0662-1000-07 Cynch TPLIF: 7mm Detachable Trial ZS 1904-010 Tissue Dilator#1 ZS 601-031-S BacFix TI Rod Releaser (Screw Lever) ZS 3554-100 Pedicle Access Tool Sheath 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 0662-1000-11 Cynch TPLIF: 11mm Detachable Trial Pioneer 0262-1001 Cequence, Counter Torque Wrench II ZS 601-044 BacFix TI Large OD Flexible Angle Implante Holder- Fixed T-Handle ZS 3354-3 Pedicle Sounder Straight Stiff ZS 1191-1 Pathfinder Rod Reducer 20MM ZS 2151-14 Socket Head Pencil Grip Starter ZS 3373-1 Sequoia Power Rod Reducer ZS 7058-01 Nex-Link Oct Occipital Rod Reduction Forceps ZS 952-2 Multiax Scrw Implant Holder ZS 951-10 Implant Holder No Tissue Shield Thru Shaft ZS 1852-2 InFix Strut Remover ZS 1911-19-1140 Radiolucent Dilator #4 (19MM X 1 Spine Smith 0150-0100 Cimplicity: Forceps Style Cervical Implant Holder 13mm(W) x 10mm(D) Spine Smith 0151-4065 Cimplicity:Parallel Trial 13mm(W) x 10mm(D) x 6.5mm(H) Spine Smith 0661-1000-07 Cynch: Detachable Spreader 7mm Spine Smith 0151-2095 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x 9.5mm(H) Spine Smith 0355-0810 Visualif: Medium 29mm x 36mm Trial: 8mm x 10° ZS 3367-2 Dorsal Height and Revision Tool ZS 9259-002 Pedestal Tap Straight Handle ZS 2761-1 T-Handle with J-Hook ZS 951-11 Bacfix Ti Bone Screw Implant Holder II-Modular Spine Smith 0150-0130 Cimplicity: Forceps Style Cervical Implant Holder 17mm(W)x14mm(D) Spine Smith 0151-4075 Cimplicity:Parallel Trial 13mm(W) x 10mm(D) x 7.5mm(H) Spine Smith 0662-1000-09 Cynch TPLIF: 9mm Detachable Trial Spine Smith 0151-1105 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 10.5mm(H) Spine Smith 0151-2075 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x 7.5mm(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 3560-1 Tissue Dilation Wedge ZS 3366-1 Screw Head Adjuster Spine Smith 0151-0095 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 9.5mm(H) Spine Smith 0151-1085 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 8.5mm(H) Spine Smith 0355-1015 Visualif: Medium 29mm x 36mm Trial: 10mm x 15° Spine Smith 0151-1065 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 6.5mm(H) Pioneer 0252-0001 Temp Fixation Screw-Pin Inserter/Remover Spine Smith 0151-0055 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 5.5mm(H) Spine Smith 0151-1095 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 9.5mm(H) Spine Smith 0355-1410 Visualif: Medium 29mm x 36mm Trial: 14mm x 10° ZS 973-10 Bacfix Ti Rod Popper III Spine Smith 0151-0085 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 8.5mm(H) Zimmer 1904-040, Tissue Dilator #4 Zimmer 1904-010, Tissue Dilator #1 ZS 7069-01 Nex-Link Oct Closed Screw Offset Connector Counter Torque Zimmer 1155-4, Cannulated T-Handle Bone Awl I Zimmer 1904-030, Tissue Dilator #3 Zimmer 1904-020, Tissue Dilator #2 ZS 871-101 Double Action Rod Gripper-Hold Zimmer 1904-050, Tissue Dilator #5 Zimmer 7069-01, Nex-Link OCT Closed Screw Offset Connector Counter Torque Zimmer 1904-060, Tissue Dilator #6 Nail Fixation Bolt DWG-04-1010-5010 RSS Glenosphere Removal Handle-S DWG-04-0961-067-501 Fin-Lock Punch DWG-04-0926-512 Talar Impactor DWG-04-1020-3098 Insert Inserter DWG-04-1020-3007 Driver Shaft-3.5mm Hex Screwdriver DWG-04-1010-5020 MUH Back Table Assy Pad DWG-04-605-007 Tibial Impactor Adapter DWG-04-1020-4106 Tibial Impactor Stop DWG-04-1020-3108 Fixation Bolt Lock Screw DWG-04-1010-5053 Talar Cut Guide - Large DWG-04-1020-3032 Talar Cut Guide- Small DWG-04-1020-3031 MUH Trial Collar Medium DWG-04-605-003 Compression Wheel DWG-04-1010-5025 Tissue Protector Removal Tool DWG-04-1010-5052 Target Guide Support DWG-04-1010-5021 ZS 1877-300 Locker-Medium ZS 2160-1 Rod Holder Gripper- Straight Tip ZS 871-200 Bacfix Rod Holder: 5.5mm/6mm Rods ZS 1871-1 InFix Endcap Inserter ZS 1755-01 Ant-Cer Single Level Restrictor Plate Removal Driver Spine Smith 0150-0010 Cimplicity: Kerrison Style Cervical Implant Holder Spine Smith 0151-4085 Cimplicity:Parallel Trial 13mm(W) x 10mm(D) x 8.5mm(H) Spine Smith 0660-1000 Cynch: Detachable Spreader Handle ZS 875-2 Bacfix Parallel Distracter Spine Smith 0151-2085 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x8.5mm(H) Spine Smith 0355-1415 Visualif: Medium 29mm x 36mm Trial: 14mm x 15° Spine Smith 0662-1000-14 Cynch TPLIF: 14mm Detachable Trial ZIMMER ITEM NO 6220-01-001 NKII REV A/P CHMFR BLOCK ZS 1904-040 Tissue Dilator #4 ZS 2162-1 All Mighty Reduction Instrument ZS 955-6 Bacfix Cannulated Provisional Locker Spine Smith 0355-1405 Visualif: Medium 29mm x 36mm Trial: 14mm x 5° ZS 3559-3 Screw Assembly Tool Spine Smith 0151-0105 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 10.5mm(H) ZS 1904-020 Tissue Dilator #2 ZS 1868-12 Shim, 12MM ZS 1868-08 Shim, 08MM ZS 3567-10 Power Knob Rod Reducer Short ZS 3565-1 Percutaneous Rod Pusher ZS 951-2 Bacfix Ti Bone Screw implant Holder II (with T-Handle) Spine Smith 0355-1010 Visualif: Medium 29mm x 36mm Trial: 10mm x 10° Spine Smith 0661-1000-09 Cynch: Detachable Spreader 9mm Spine Smith 0355-1005 Visualif: Medium 29mm x 36mm Trial: 10mm x 5° Spine Smith 0662-1000-13 Cynch TPLIF: 13mm Detachable Trial ZS 963-1 Bacfix Ti Serrated Tooth Locking Clip Sizer Spine Smith 0150-0150 Cimplicity: Shaft Style Cervical Implant Holder ZS 1904-060 Tissue Dilator #6 ZS 3354-2 Pedicle Sounder Straight Flexible Spine Smith 0662-1000-12 Cynch TPLIF: 12mm Detachable Trial ZS 3551-010 Tissue Dilator A Pioneer 0251-0001 Cequence Cervical Plate Holder Spine Smith 0151-0075 Cimplicity: Lordotic Trial 13mm(W) x 10mm(D) x 7.5mm(H) Spine Smith 0151-2055 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x 5.5mm(H) ZS 969-20 Bacfix rod retainer Tube (for Swizzle Stick) ZS 2151-13 Socket Head Starter with Knob ZS 3573-10 Fixed Percutaneous Rod Holder ZS 952-1 Implant Holder Bacfix Ti, Multiaxial Screw Driver (Modular) Spine Smith 0355-0815 Visualif: Medium 29mm x 36mm Trial: 8mm x 15° Spine Smith 0662-1000-08 Cynch TPLIF: 8mm Detachable Trial Spine Smith 0151-1055 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 5.5mm(H) ZS 1868-10 Shim, 10MM ZS 601-124 BacFix TI Multi-Axial Screw Implant Holder ZS 3354-1 Pedicle Sounder Curved Flexible ZS 3567-20 Power Knob Rod Reducer Long Spine Smith 0151-2105 Cimplicity: Angled Shaft Lordotic Trial w/stop 13mm(W) x 10mm(D) x 10.5mm(H) Spine Smith 0355-1210 Visualif: Medium 29mm x 36mm Trial: 12mm x 10° ZS 1877-500 Locker-Large ZS 2151-5 Set-Screw T-Handle (7/32" Hex) Quick Release Long Shaft ZS 1904-030 Tissue Dilator #3 ZS 3551-020 Tissue Dilator B Spine Smith 0151-1075 Cimplicity: Lordotic Trial w/stop 13mm(W) x 10mm(D) x 7.5mm(H) Spine Smith 0151-4055 Cimplicity: Parallel Trial 13mm(W) x 10mm(D) x 5.5mm(H) Spine Smith 0150-0030 Cimplicity: Kerrison Tip 17mm(W) x 14mm(D) Spine Smith 0662-1000-15 Cynch TPLIF: 15mm Detachable Trial ZS 1868-14 Shim, 14MM ZS 2159-3 Axis Finder: T-Bar Handle ZS 156-1 SS Monofilament Jet Wire Twist ZS 07168701 Compressor Tip, L Inferior ZS 07168301 Compressor Tip, S Inferior ZS 07168201 Compressor Tip, Superior ZS 07168501 Compressor Tip, M Inferior ZS 601-038-4C Pedicle Probe Shaft 4MM Curved (Quick Release) ZS 601-034-4724 Ped Prb2 3mm w/Ortho TRDRP Imp ZS 601-097-L Removable Probe Tip (Left) ZS 601-097-R Removable Probe Tip (Right) ZS 601-038-3 BacFix Pedicle Probe Shaft 3MM Straight Quick Release Ascension, Prosthesis, Finger, Constrained, Polymer 2mm X 150mm Guide Pins DWG-04-895-019 ZS 7002-01 OCTA II Connector ZS 7001-01 OCTA II Plate Ascension, High demand, revision, semi-constrained, pyrolitic carbon, uncemented finger prosthesis ZS 876-3 BacFix Parallel Compressor ZS 876-32 BacFix Parallel Compressor- Narrow Jaw ZS 876-31 BacFix Parallel Compressor-Extra Wide Jaws ZS 1879-500 Guide-Large Pioneer 431-278 Locking Guide, Single Barrel, 10° Right ZS 1857-500 Endplate Trial, Large ZS 2665-1-11 Traxis Trial, 11MM Pioneer 24-DBGUIDE-S-0 Guide, Standard, Double Barrel, 0° Pioneer 431-280 Locking Guide, Single Barrel, 0° ZS 485-1 Fixed ACP Double Barrel Drill Guide- Slimline ZS 2665-1-15 Traxis Trial, 15MM ZS 2666-110925 Trial 11MM X 09MM X 25MM ZS 2666-151125 Trial 15MM X 11MM X 25MM ZS 2666-111121 Trial 11MM X 11MM X 21MM Pioneer 0254-2011 Cequence, DB Drill Guide, End Holes ZS 2666-090921 Trial 09MM X 09MM X 21MM ZS 1879-300 Guide-Medium Pioneer 24-DBGUIDE-S-10 Guide, Standard, Double Barrel, 10° Pioneer 24-SBGUIDE-S-10-R Guide, Standard, Single Barrel, 10° Right ZS 1874-500 Guide Impact Cap, Large Pioneer 0254-2010 Cequence, DB Drill Guide, Middle Holes ZS 2159-6 Guide Tube Pioneer 24-SBGUIDE-S-0 Guide, Standard, Single Barrel, 0° ZS 7076-01 Nex-Link Oct Flexible Instrument Guidance Tool Ascension ALG-100-00 Alignment Guide Integra OSG-200-20P PIP, Proximal Cut Guide, Sz. 20 Integra OSG-200-20PV PIP Prox Cut Guide, Volar Appr, Sz. 20 Integra OSG-200-30P PIP, Proximal Cut Guide, Sz. 30 Ascension OSG-350-01 Osteotomy Cut Guide, MRH Integra OSG-200-30PV PIP Prox Cut Guide, Volar Appr, Sz. 30 Integra OSG-200-40P PIP, Proximal Cut Guide, Sz. 40 Integra OSG-200-00 PIP Vertical Cut Guide Integra OSG-200-40PV PIP Prox Cut Guide, Volar Appr, Sz. 40 Integra OSG-200-10PV PIP Prox Cut Guide, Volar Appr, Sz. 10 Integra OSG-200-10P PIP, Proximal Cut Guide, Sz. 10 RSS Double Drill Guide DWG-04-0961-077-501 DRUJ Osteotomy Guide DWG-04-615-001 Definitive Stem RSS Reamer Guide Body, SML DWG-0960-044-502 Talar Chamfer Drill Guide DWG-04-1020-4033 Definitive Stem RSS Reamer Guide Body, LRG DWG-0960-044-502 MUH Osteotomy Guide DWG-04-605-008 Definitive Stem RSS Reamer Guide Body, STD DWG-0960-044-502 ZS 2665-1-07 Traxis Trial, 7MM ZS 2666-131125 Trial 13MM X 11MM X 25MM ZS 1874-100 Guide Impact Cap, Small ZS 2666-131121 Trial 13MM X 11MM X 21MM ZS 2666-090925 Trial 09MM X 09MM X 25MM Pioneer 431-250 Locking Guide, Single Barrel, 10° Left Pioneer 24-SBGUIDE-S-10-L Guide, Standard, Single Barrel, 10° Left ZS 601-019-S50 Pedicle Scre Marker- 50mm ZS 1857-100 Endplate Trial, Small ZS 601-019-S Pedicle Screw Marker 30mm ZS 2666-110921 Trial 11MM X 09MM X 21MM ZS 2666-151121 Trial 15MM X 11MM X 21MM ZS 1874-300 Guide Impact Cap, Medium ZS 2665-1-13 Traxis Trial, 13MM ZS 1879-100 Guide-Small ZS 2666-111125 Trial 11MM X 11MM X 25MM ZS 2665-1-09 Traxis Trial, 9MM ZS 1857-300 Endplate Trial, Medium Pioneer 0254-0021 Cequence, Constrained SB Drill Guide II Spine Smith 1103-0090 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 9mm(H) Spine Smith 1101-0050 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 5mm(H) Spine Smith 1103-0050 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 5mm(H) Spine Smith 1103-0110 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 11mm(H) Spine Smith 1102-0050 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 5mm(H) Spine Smith 1101-0110 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 11mm(H) Spine Smith 1102-0070 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 7mm(H) Spine Smith 1101-0080 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 7mm(H) Spine Smith 1102-0090 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 9mm(H) Spine Smith 1101-0090 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 9mm(H) Spine Smith 1101-0070 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 6.5mm(H) Spine Smith 1103-0100 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 10mm(H) Spine Smith 1102-0100 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 10mm(H) Spine Smith 1103-0080 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 8mm(H) Spine Smith 1103-0060 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 6mm(H) Spine Smith 1102-0060 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 6mm(H) Spine Smith 1102-0110 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 11mm(H) Spine Smith 1101-0060 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 6mm(H) Spine Smith 1103-0070 IN:C2 PEEK Lordotic (6°) Implant 18mm(W) x 15mm(D) x 7mm(H) Spine Smith 1101-0100 IN:C2 PEEK Lordotic (6°) Implant 14mm(W) x 11.5mm(D) x 10mm(H) Spine Smith 1102-0080 IN:C2 PEEK Lordotic (6°) Implant 16mm(W) x 13mm(D) x 8mm(H) ZS 2664-1-09 Traxis Rasp, 9MM ZS 2664-1-11 Traxis Rasp, 11MM ZS 2664-1-07 Traxis Rasp, 7MM ZS 2664-1-15 Traxis Rasp, 15MM ZS 2664-1-13 Traxis Rasp, 13MM ZS 878-1 Tee Handle Wrench 3/8" Socket Drive ZS 3568-3 Counter Torque Wrench ZS 974-1 BacFix Rod Rotation Wrench 5/32" Straight and Angled Spine Smith 0602-0140 Cynch TLIF: 5° x 11mm x 25mm x 14mm Spine Smith 0611-3308-06 Cynch Lordotic TPLIF: 11mm x 33mm x 8mm x 6° Spine Smith 0611-3313-06 Cynch Lordotic TPLIF: 11mm x 33mm x 13mm x 6° Spine Smith 0609-2812 Cynch Straight TPLIF: 9mm x 28mm x 12mm Spine Smith 0609-2808 Cynch Straight TPLIF: 9mm x 28mm x 8mm Spine Smith 0609-2815-06 Cynch Lordotic TPLIF: 9mm x 28mm x 15mm x 6° Spine Smith 0601-0080 Cynch TLIF: 5° x 11mm x 30mm x 8mm Spine Smith 0609-2807 Cynch Straight TPLIF: 9mm x 28mm x 7mm Spine Smith 0611-3310 Cynch Straight TPLIF: 11mm x 33mm x 10mm Spine Smith 0609-3307-06 Cynch Lordotic TPLIF: 9mm x 33mm x 7mm x 6° Spine Smith 0601-0090 Cynch TLIF: 5° x 11mm x 30mm x 9mm Spine Smith 0602-0070 Cynch TLIF: 5° x 11mm x 25mm x 7mm Spine Smith 0609-2313 Cynch Straight TPLIF: 9mm x 23mm x 13mm Spine Smith 0611-3312 Cynch Straight TPLIF: 11mm x 33mm x 12mm Spine Smith 0609-3311-06 Cynch Lordotic TPLIF: 9mm x 33mm x 11mm x 6° Spine Smith 0602-0090 Cynch TLIF: 5° x 11mm x 25mm x 9mm Spine Smith 0609-2314-06 Cynch Lordotic TPLIF: 9mm x 23mm x 14mm x 6° Spine Smith 0611-3314-06 Cynch Lordotic TPLIF: 11mm x 33mm x 14mm x 6° Spine Smith 0611-2815-06 Cynch Lordotic TPLIF: 11mm x 28mm x 15mm x 6° Spine Smith 0609-2310 Cynch Straight TPLIF: 9mm x 23mm x 10mm Spine Smith 0609-2808-06 Cynch Lordotic TPLIF: 9mm x 28mm x 8mm x 6° Spine Smith 0609-3308 Cynch Straight TPLIF: 9mm x 33mm x 8mm Spine Smith 0602-0100 Cynch TLIF: 5° x 11mm x 25mm x 10mm Spine Smith 0609-2312 Cynch Straight TPLIF: 9mm x 23mm x 12mm Spine Smith 0611-3308 Cynch Straight TPLIF: 11mm x 33mm x 8mm Spine Smith 0609-2311 Cynch Straight TPLIF: 9mm x 23mm x 11mm Spine Smith 0609-2811-06 Cynch Lordotic TPLIF: 9mm x 28mm x 11mm x 6° Spine Smith 0609-2309-06 Cynch Lordotic TPLIF: 9mm x 23mm x 9mm x 6° Spine Smith 0609-2814-06 Cynch Lordotic TPLIF: 9mm x 28mm x 14mm x 6° Spine Smith 0601-0140 Cynch TLIF: 5° x 11mm x 30mm x 14mm Spine Smith 0609-2310-06 Cynch Lordotic TPLIF: 9mm x 23mm x 10mm x 6° Spine Smith 0609-3310 Cynch Straight TPLIF: 9mm x 33mm x 10mm Spine Smith 0609-3309 Cynch Straight TPLIF: 9mm x 33mm x 9mm Spine Smith 0609-2311-06 Cynch Lordotic TPLIF: 9mm x 23mm x 11mm x 6° Spine Smith 0609-3309-06 Cynch Lordotic TPLIF: 9mm x 33mm x 9mm x 6° Spine Smith 0609-2813 Cynch Straight TPLIF: 9mm x 28mm x 13mm Spine Smith 0611-3311-06 Cynch Lordotic TPLIF: 11mm x 33mm x 11mm x 6° Spine Smith 0602-0110 Cynch TLIF: 5° x 11mm x 25mm x 11mm Spine Smith 0609-2315 Cynch Straight TPLIF: 9mm x 23mm x 15mm Spine Smith 0609-3313 Cynch Straight TPLIF: 9mm x 33mm x 13mm Spine Smith 0602-0080 Cynch TLIF: 5° x 11mm x 25mm x 8mm Spine Smith 0601-0120 Cynch TLIF: 5° x 11mm x 30mm x 12mm Spine Smith 0609-2308-06 Cynch Lordotic TPLIF: 9mm x 23mm x 8mm x 6° Spine Smith 0611-3311 Cynch Straight TPLIF: 11mm x 33mm x 11mm Spine Smith 0609-3312 Cynch Straight TPLIF: 9mm x 33mm x 12mm Spine Smith 0602-0150 Cynch TLIF: 5° x 11mm x 25mm x 15mm Spine Smith 0609-2309 Cynch Straight TPLIF: 9mm x 23mm x 9mm Spine Smith 0609-3314-06 Cynch Lordotic TPLIF: 9mm x 33mm x 14mm x 6° Spine Smith 0602-0130 Cynch TLIF: 5° x 11mm x 25mm x 13mm Spine Smith 0611-3314 Cynch Straight TPLIF: 11mm x 33mm x 14mm Spine Smith 0611-3313 Cynch Straight TPLIF: 11mm x 33mm x 13mm Spine Smith 0601-0130 Cynch TLIF: 5° x 11mm x 30mm x 13mm Spine Smith 0611-3309 Cynch Straight TPLIF: 11mm x 33mm x 9mm Spine Smith 0602-0120 Cynch TLIF: 5° x 11mm x 25mm x 12mm Spine Smith 0609-2814 Cynch Straight TPLIF: 9mm x 28mm x 14mm Spine Smith 0609-2810-06 Cynch Lordotic TPLIF: 9mm x 28mm x 10mm x 6° Spine Smith 0611-3315-06 Cynch Lordotic TPLIF: 11mm x 33mm x 15mm x 6° Spine Smith 0609-2815 Cynch Straight TPLIF: 9mm x 28mm x 15mm Spine Smith 0611-3307-06 Cynch Lordotic TPLIF: 11mm x 33mm x 7mm x 6° Spine Smith 0609-2811 Cynch Straight TPLIF: 9mm x 28mm x 11mm Spine Smith 0611-3309-06 Cynch Lordotic TPLIF: 11mm x 33mm x 9mm x 6° Spine Smith 0609-2810 Cynch Straight TPLIF: 9mm x 28mm x 10mm Spine Smith 0609-2809-06 Cynch Lordotic TPLIF: 9mm x 28mm x 9mm x 6° Spine Smith 0611-3312-06 Cynch Lordotic TPLIF: 11mm x 33mm x 12mm x 6° Spine Smith 0609-2813-06 Cynch Lordotic TPLIF: 9mm x 28mm x 13mm x 6° Spine Smith 0611-2807-06 Cynch Lordotic TPLIF: 11mm x 28mm x 7mm x 6° Spine Smith 0611-2310 Cynch Straight TPLIF: 11mm x 23mm x 10mm Spine Smith 0611-2814 Cynch Straight TPLIF: 11mm x 28mm x 14mm Spine Smith 0611-2813-06 Cynch Lordotic TPLIF: 11mm x 28mm x 13mm x 6° Spine Smith 0611-2315 Cynch Straight TPLIF: 11mm x 23mm x 15mm Spine Smith 0611-2809-06 Cynch Lordotic TPLIF: 11mm x 28mm x 9mm x 6° Spine Smith 0611-2315-06 Cynch Lordotic TPLIF: 11mm x 23mm x 15mm x 6° Spine Smith 0611-2311-06 Cynch Lordotic TPLIF: 11mm x 23mm x 11mm x 6° Spine Smith 0611-2815 Cynch Straight TPLIF: 11mm x 28mm x 15mm Spine Smith 0611-2309-06 Cynch Lordotic TPLIF: 11mm x 23mm x 9mm x 6° Spine Smith 0611-2308-06 Cynch Lordotic TPLIF: 11mm x 23mm x 8mm x 6° Spine Smith 0611-2810-06 Cynch Lordotic TPLIF: 11mm x 28mm x 10mm x 6° Spine Smith 0611-2307-06 Cynch Lordotic TPLIF: 11mm x 23mm x 7mm x 6° Spine Smith 0611-2809 Cynch Straight TPLIF: 11mm x 28mm x 9mm Spine Smith 0611-2814-06 Cynch Lordotic TPLIF: 11mm x 28mm x 14mm x 6° Spine Smith 0611-2311 Cynch Straight TPLIF: 11mm x 23mm x 11mm Spine Smith 0611-2312 Cynch Straight TPLIF: 11mm x 23mm x 12mm Spine Smith 0611-2813 Cynch Straight TPLIF: 11mm x 28mm x 13mm Spine Smith 0611-2312-06 Cynch Lordotic TPLIF: 11mm x 23mm x 12mm x 6° Spine Smith 0611-2314-06 Cynch Lordotic TPLIF: 11mm x 23mm x 14mm x 6° Spine Smith 0611-2812-06 Cynch Lordotic TPLIF: 11mm x 28mm x 12mm x 6° Spine Smith 0611-2309 Cynch Straight TPLIF: 11mm x 23mm x 9mm Spine Smith 0611-2808 Cynch Straight TPLIF: 11mm x 28mm x 8mm Spine Smith 0611-2314 Cynch Straight TPLIF: 11mm x 23mm x 14mm Spine Smith 0611-2313 Cynch Straight TPLIF: 11mm x 23mm x 13mm Spine Smith 0611-2808-06 Cynch Lordotic TPLIF: 11mm x 28mm x 8mm x 6° Spine Smith 0611-2811 Cynch Straight TPLIF: 11mm x 28mm x 11mm Spine Smith 0611-2308 Cynch Straight TPLIF: 11mm x 23mm x 8mm Spine Smith 0611-2310-06 Cynch Lordotic TPLIF: 11mm x 23mm x 10mm x 6° Spine Smith 0609-3315 Cynch Straight TPLIF: 9mm x 33mm x 15mm Spine Smith 0609-3311 Cynch Straight TPLIF: 9mm x 33mm x 11mm Spine Smith 0611-2811-06 Cynch Lordotic TPLIF: 11mm x 28mm x 11mm x 6° Spine Smith 0611-2812 Cynch Straight TPLIF: 11mm x 28mm x 12mm Spine Smith 0611-2313-06 Cynch Lordotic TPLIF: 11mm x 23mm x 13mm x 6° Spine Smith 0609-3310-06 Cynch Lordotic TPLIF: 9mm x 33mm x 10mm x 6° Spine Smith 0611-2810 Cynch Straight TPLIF: 11mm x 28mm x 10mm Spine Smith 0601-0110 Cynch TLIF: 5° x 11mm x 30mm x 11mm Spine Smith 0609-2307-06 Cynch Lordotic TPLIF: 9mm x 23mm x 7mm x 6° Spine Smith 0609-3307 Cynch Straight TPLIF: 9mm x 33mm x 7mm Spine Smith 0601-0150 Cynch TLIF: 5° x 11mm x 30mm x 15mm Spine Smith 0609-2313-06 Cynch Lordotic TPLIF: 9mm x 23mm x 13mm x 6° Spine Smith 0609-2308 Cynch Straight TPLIF: 9mm x 23mm x 8mm Spine Smith 0611-3310-06 Cynch Lordotic TPLIF: 11mm x 33mm x 10mm x 6° Spine Smith 0609-3312-06 Cynch Lordotic TPLIF: 9mm x 33mm x 12mm x 6° Spine Smith 0609-2807-06 Cynch Lordotic TPLIF: 9mm x 28mm x 7mm x 6° Spine Smith 0609-3308-06 Cynch Lordotic TPLIF: 9mm x 33mm x 8mm x 6° Spine Smith 0602-0060 Cynch TLIF: 5° x 11mm x 25mm x 6mm Spine Smith 0601-0100 Cynch TLIF: 5° x 11mm x 30mm x 10mm Spine Smith 0611-3315 Cynch Straight TPLIF: 11mm x 33mm x 15mm Spine Smith 0609-3314 Cynch Straight TPLIF: 9mm x 33mm x 14mm Spine Smith 0609-2314 Cynch Straight TPLIF: 9mm x 23mm x 14mm Spine Smith 0609-3315-06 Cynch Lordotic TPLIF: 9mm x 33mm x 15mm x 6° Spine Smith 0609-2315-06 Cynch Lordotic TPLIF: 9mm x 23mm x 15mm x 6° Spine Smith 0609-3313-06 Cynch Lordotic TPLIF: 9mm x 33mm x 13mm x 6° Spine Smith 0609-2812-06 Cynch Lordotic TPLIF: 9mm x 28mm x 12mm x 6° Spine Smith 0609-2312-06 Cynch Lordotic TPLIF: 9mm x 23mm x 12mm x 6° Spine Smith 0609-2809 Cynch Straight TPLIF: 9mm x 28mm x 9mm Ascension, Prosthesis, Wrist, Carpal, Trapezium Integra IMP-0920-079-501 Impactor, Head, TXX FGT Impactor DWG-04-1310-5067-001 RSS Glenoid Baseplate Impactor-S DWG-04-0961-064-501 ZS 156-1 SS Monofilament Jet Wire Twist ZS 1190-10 Pathfinder Complete Base/Tray ZS 1190-11 Complete Lid ZS 3372-1 Sequoia Rod Reduction Forceps ZS 1167-3 Sleeve Based Forceps Reducer ZS 2165-1 Straight Hook Holder Forceps ZS 9251-10 Thoracolumbar Forceps Style Screw/Hook Distracter II ZS 969-1 Rod Tetention Forceps (Machined Complete) ZS 9252-10 Thoracolumbar Forceps Style Screw/Hook Compressor II ZS 955-20 BacFix TI Provisional Locking Forceps- Angled ZS 959-3 Bac Fix Lateral/Medial Translation Forceps ZS 882-1 Straight Hook Holder Forceps (Machined Complete) ZS 2162-20 Rod Reduction Forceps ZS 882-2 Angled Hook Holder Forceps (Machined Complete) ZS 3369-1 Rod Forceps ZS 403-4072 ACP 4 Lvl Spiked Plate 72mm Zimmer 10403-2144 ACP 2 LVL SPKLESS HYBRID PLATE Integra EXT-910-00 Titan Extractor Integra EXT-100-01 MCP, Extractor, Implant RSS Reamer Guide Body Inserter/Extractor DWG-04-0961-049-501 RSS Humeral Body Inserter/Extractor DWG-04-0961-048-501 ZS 2667-2 Traxis Inserter/Extractor ZS 971-1 BacFix TI, Rod C-Clamp Corner Osteotome DWG-04-1020-4078 Corner Osteotome DWG-04-1020-4079 ZS 1804-510 Strut, Large, 10mm ZS 1803-10 InFix Endcap, 10MM ZS 1803-08 InFix Endcap, 08MM ZS 1803-12, InFix Endcap, 12MM ZS 1804-310 Strut, Medium, 10mm ZS 1803-14 InFix Endcap, 14MM ZS 1804-112 Strut, Small, 12mm ZS 1804-110 Strut, Small, 10mm ZS 1804-108 Strut, Small, 08MM ZS 1804-508 Strut, Large, 08mm ZS 1804-512 Strut, Large, 12mm ZS 1804-308 Strut, Medium, 08mm ZS 1804-312 Strut, Medium, 12mm ZS 1804-514 Strut, Large, 14mm ZS 1804-114 Strut, Small 14mm ZS 1804-314 Strut, Medium, 14mm Full Ring 180MM DWG-04-1222-4122 ZS 1910-30 Flexible Table Arm ZS 1910-10 Table Clamp ZS 1931-1 Table Clamp, S.A.M.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-05-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-05-08
HTO	Reamer	Orthopedic	Class 1	888.4540	2018-10-23
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-04-08
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-03-26
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-04-08
NEG	Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis	Unknown	Class 3	N/A	2013-04-08
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-04-08
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-05-10
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-05-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-05-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-05-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-05-08
HTQ	Broach	Orthopedic	Class 1	888.4540	2013-04-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-04-08
DZK	Wire, Fixation, Intraosseous	Dental	Class 2	872.4880	2013-04-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-02-12
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2014-01-23
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2013-04-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-04-11
HXB	Probe	Orthopedic	Class 1	888.4540	2013-04-08
KYJ	Prosthesis, Finger, Constrained, Polymer	Orthopedic	Class 2	888.3230	2013-04-08
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2018-10-23
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-04-08
OMX	High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis	Unknown	Class f	N/A	2013-04-08
NEG	Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis	Unknown	Class 3	N/A	2013-04-08
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2013-04-08
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-12-13
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-05-13
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-04-08
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-04-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-05-13
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2013-04-08
HWA	Impactor	Orthopedic	Class 1	888.4540	2014-01-22
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2013-04-08
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-04-08
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-04-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-01-13
HWB	Extractor	Orthopedic	Class 1	888.4540	2013-04-08
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2013-04-08
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-04-08
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2018-10-23
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-04-11
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2013-04-08
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2018-10-23
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2013-04-08

Official Correspondent

Burke Ramsay

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Banister Tool, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649379. Last updated year: 2026. Please use registration number 1649379 when referencing this establishment in official correspondence.