Vail Alif Buttress Plate System
Vail ALIF Buttress Plate maintains the relative position of weak bony tissue, including autograft or allograft, during spinal fusion. It is an anterior, non-load-bearing titanium-alloy…
Vail ALIF Buttress Plate maintains the relative position of weak bony tissue, including autograft or allograft, during spinal fusion. It is an anterior, non-load-bearing titanium-alloy plate used with traditional rigid fixation.
The plate has an angled, flanged shape and uses spike features with a single screw for fixation. A surgeon-engaged visible lock provides feedback during fixation, and different shapes and sizes accommodate anatomy.
Listed Item
22mm 25 Deg Buttress Plate
Use Conditions
The indicated region extends from the thoracolumbar spine to S1. The single-use implant is supplied nonsterile for moist-heat sterilization by the user and is not intended for load-bearing applications.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Evolution Spine, LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K180755 |
| Record published | 2021-06-12 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 20 to 26 mm; angle 6 to 30 °; outer diameter 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BP1225 | Length 25 mm | In distribution |
| BP132225 | Angle 25 ° | In distribution |
| BP132230 | Length 22 mm | In distribution |
| BP132220 | Angle 20 ° | In distribution |
| BP132630 | Angle 30 ° | In distribution |
| BP1220 | Length 20 mm | In distribution |
| BP132625 | Angle 25 ° | In distribution |
| BP132606 | Length 26 mm | In distribution |
| BP132430 | Angle 30 ° | In distribution |
| BP132006 | Angle 6 ° | In distribution |
| BP132425 | Length 24 mm | In distribution |
| BP132525 | Length 20 mm | In distribution |
| BP132020 | Angle 20 ° | In distribution |
| BP132620 | Length 26 mm | In distribution |
| BP132420 | Length 24 mm | In distribution |
| BP132206 | Angle 6 ° | In distribution |
| BP133030 | Length 20 mm | In distribution |
| BP132406 | Length 24 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220275 | 2022-03-18 |
| K212405 | 2021-09-30 |
| K180755 | 2018-07-06 |
| K173375 | 2017-12-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.