FDA Registration
Active
🇺🇸 United States
ZS 2106-5540 5.5mm Fixed Angle Screw-Closed 5
Reg #: 1649379
·
FEI: 3000718490
·
Expires 2025
Products
4
Proprietary Names
121
Establishment Types
1
Classifications
4
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
- K021564
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-05-08 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-05-08 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-05-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-05-08 |
Proprietary Names
ZS 2106-5540 5.5mm Fixed Angle Screw-Closed 5
ZS 2203-4535 1/4" SS Fixed Angle Screw Open 4.5 x 35
ZS 2203-7545 1/4" SS Fixed Angle Screw Open 7.5 x 45
ZS 2206-7540 1/4" SS Fixed Angle Screw Closed 7.5 x 40
ZS 2106-4525 5.5mm Fixed Angle Screw-Closed 4
ZS 2106-7545 5.5mm Fixed Angle Screw-Closed 7
ZS 2106-5545 5.5mm Fixed Angle Screw-Closed 5
ZS 2203-7555 1/4" SS Fixed Angle Screw Open 7.5 x 55
ZS 2206-4530 1/4" SS Fixed Angle Screw Closed 4.5 x 30
ZS 2206-6550 1/4" SS Fixed Angle Screw Closed 6.5 x 50
ZS 2203-6545 1/4" SS Fixed Angle Screw Open 6.5 x 45
ZS 2203-5525 1/4" SS Fixed Angle Screw Open 5.5 x 25
ZS 2204-11W-SB 1/4" SS Wide Standard Body Hook Open
ZS 2206-6540 1/4" SS Fixed Angle Screw Closed 6.5 x 40
ZS 2203-7590 1/4" SS Fixed Angle Screw Open 7.5 x 90
ZS 2102-130 5.5mm TI Offset Connector Closed 30mm
ZS 2204-11N-EB 1/4" SS Narrow Extended Body Hook Open
ZS 2106-4530 5.5mm Fixed Angle Screw-Closed 4
ZS 2106-8540 5.5mm Fixed Angle Screw-Closed 8
ZS 2106-5530 5.5mm Fixed Angle Screw-Closed 5
ZS 2202-130 1/4" SS Offset Connector Clsd
ZS 2203-7535 1/4" SS Fixed Angle Screw Open 7.5 x 35
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 2106-8590 5.5mm Fixed Angle Screw-Closed 8
ZS 2106-6530 5.5mm Fixed Angle Screw-Closed 6
ZS 2106-8545 5.5mm Fixed Angle Screw-Closed 8
ZS 2203-5530 1/4" SS Fixed Angle Screw Open 5.5 x 30
ZS 2203-5535 1/4" SS Fixed Angle Screw Open 5.5 x 35
ZS 2106-8580 5.5mm Fixed Angle Screw-Closed 8
ZS 2203-8570 1/4" SS Fixed Angle Screw Open 8.5 x 70
ZS 2203-7570 1/4" SS Fixed Angle Screw Open 7.5 x 70
ZS 2106-6555 5.5mm Fixed Angle Screw-Closed 6
ZS 2203-8540 1/4" SS Fixed Angle Screw Open 8.5 x 40
ZS 2202-30 1/4" SS Offset Connector Open
ZS 2203-7540 1/4" SS Fixed Angle Screw Open 7.5 x 40
ZS 2206-4540 1/4" SS Fixed Angle Screw Closed 4.5 x 40
ZS 2206-4535 1/4" SS Fixed Angle Screw Closed 4.5 x 35
ZS 2106-5525 5.5mm Fixed Angle Screw-Closed 5
ZS 2106-7535 5.5mm Fixed Angle Screw-Closed 7
ZS 2202-175 1/4" SS Offset Connector Clsd
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 2106-6545 5.5mm Fixed Angle Screw-Closed 6
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 2203-4530 1/4" SS Fixed Angle Screw Open 4.5 x 30
ZS 2206-8545 1/4" SS Fixed Angle Screw Closed 8.5 x 45
ZS 2204-9N-SB 1/4" SS Narrow Standard Body Hook Open
ZS 2206-7570 1/4" SS Fixed Angle Screw Closed 7.5 x 70
ZS 2102-111 5.5mm TI Offset Connector Closed 11mm
ZS 2106-7560 5.5mm Fixed Angle Screw-Closed 7
ZS 2106-4540 5.5mm Fixed Angle Screw-Closed 4
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 2106-7580 5.5mm Fixed Angle Screw-Closed 7
ZS 2202-13 1/4" SS Offset Connector Open
ZS 2203-4525 1/4" SS Fixed Angle Screw Open 4.5 x 25
ZS 2206-7535 1/4" SS Fixed Angle Screw Closed 7.5 x 35
ZS 2204-P85-SB 1/4" SS PED Hook Standard Body Open
ZS 2203-7530 1/4" SS Fixed Angle Screw Open 7.5 x 30
ZS 601-025-6545-S PARS Defect Screw III Partial Thread 6.5x45
ZS 2204-9W-EB 1/4" SS Wide Extended Body Hook Open
ZS 2206-8590 1/4" SS Fixed Angle Screw Closed 8.5 x 90
ZS 2106-6540 5.5mm Fixed Angle Screw-Closed 6
ZS 2206-6525 1/4" SS Fixed Angle Screw Closed 6.5 x 25
ZS 2106-6550 5.5mm Fixed Angle Screw-Closed 6
ZS 2106-8570 5.5mm Fixed Angle Screw-Closed 8
ZS 2106-7540 5.5mm Fixed Angle Screw-Closed 7
ZS 2203-6555 1/4" SS Fixed Angle Screw Open 6.5 x 55
ZS 2203-6550 1/4" SS Fixed Angle Screw Open 6.5 x 50
ZS 2203-6530 1/4" SS Fixed Angle Screw Open 6.5 x 30
ZS 2206-5535 1/4" SS Fixed Angle Screw Closed 5.5 x 35
ZS 2203-4540 1/4" SS Fixed Angle Screw Open 4.5 x 40
ZS 2204-9W-SB 1/4" SS Wide Standard Body Hook Open
ZS 2106-8535 5.5mm Fixed Angle Screw-Closed 8
ZS 2203-7560 1/4" SS Fixed Angle Screw Open 7.5 x 60
ZS 2203-5540 1/4" SS Fixed Angle Screw Open 5.5 x 40
ZS 2203-6525 1/4" SS Fixed Angle Screw Open 6.5 x 25
ZS 2203-8535 1/4" SS Fixed Angle Screw Open 8.5 x 35
ZS 2206-7530 1/4" SS Fixed Angle Screw Closed 7.5 x 30
ZS 2203-7580 1/4" SS Fixed Angle Screw Open 7.5 x 80
ZS 2204-UL-SB 1/4" SS UP Lumbar Hook Standard Body
ZS 2102-175 5.5mm TI Offset Connector Closed 7.5mm
ZS 2204-9N-EB 1/4" SS Narrow Extended Body Hook Open
ZS 2206-6555 1/4" SS Fixed Angle Screw Closed 6.5 x 55
ZS 2106-7590 5.5mm Fixed Angle Screw-Closed 7
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 2203-8545 1/4" SS Fixed Angle Screw Open 8.5 x 45
ZS 2204-11N-SB 1/4" SS Narrow Standard Body Hook Open
ZS 2206-4525 1/4" SS Fixed Angle Screw Closed 4.5 x 25
ZS 601-025-7530 PARS Defect Screw III Closed Cannulated 7.5x30
ZS 2106-7555 5.5mm Fixed Angle Screw-Closed 7
ZS 2106-7570 5.5mm Fixed Angle Screw-Closed 7
ZS 2203-7550 1/4" SS Fixed Angle Screw Open 7.5 x 50
ZS 2206-5525 1/4" SS Fixed Angle Screw Closed 5.5 x 25
ZS 2206-7580 1/4" SS Fixed Angle Screw Closed 7.5 x 80
ZS 2106-7530 5.5mm Fixed Angle Screw-Closed 7
ZS 2202-111 1/4" SS Offset Connector Clsd
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 2106-6525 5.5mm Fixed Angle Screw-Closed 6
ZS 2202-95 1/4" SS Offset Connector Open
ZS 2203-8590 1/4" SS Fixed Angle Screw Open 8.5 x 90
ZS 2206-7545 1/4" SS Fixed Angle Screw Closed 7.5 x 45
ZS 2206-7590 1/4" SS Fixed Angle Screw Closed 7.5 x 90
ZS 2106-4535 5.5mm Fixed Angle Screw-Closed 4
ZS 2204-7N-SB 1/4" SS Narrow Standard Body Hook Open
ZS 2206-6530 1/4" SS Fixed Angle Screw Closed 6.5 x 30
ZS 2206-8530 1/4" SS Fixed Angle Screw Closed 8.5 x 30
ZS 2106-5535 5.5mm Fixed Angle Screw-Closed 5
ZS 2203-6540 1/4" SS Fixed Angle Screw Open 6.5 x 40
ZS 2206-6545 1/4" SS Fixed Angle Screw Closed 6.5 x 45
ZS 2206-7560 1/4" SS Fixed Angle Screw Closed 7.5 x 60
ZS 2106-8530 5.5mm Fixed Angle Screw-Closed 8
ZS 2203-5545 1/4" SS Fixed Angle Screw Open 5.5 x 45
ZS 2203-6535 1/4" SS Fixed Angle Screw Open 6.5 x 35
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)