Vuelock® Anterior Cervical
57 catalogue numbers from 83114E, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
57catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Biomet Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2020-06-27 |
| Record revised | 2025-07-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 83114E | ONE LEVEL 14 MM PLATE | In distribution |
| 83122E | ONE LEVEL 22 MM PLATE | In distribution |
| 83468E | FOUR LEVEL 68 MM PLATE | In distribution |
| 83476E | FOUR LEVEL 76 MM PLATE | In distribution |
| 83344E | THREE LEVEL 44 MM PLATE | In distribution |
| 83356E | THREE LEVEL 56 MM PLATE | In distribution |
| 63050E | 5.0 MM X 12 MM BONE SCREW | In distribution |
| 63027E | 4.0 MM X 14 MM BONE SCREW | In distribution |
| 83232E | TWO LEVEL 32 MM PLATE | In distribution |
| 83234E | TWO LEVEL 34 MM PLATE | In distribution |
| 83242E | TWO LEVEL 42 MM PLATE | In distribution |
| 83350E | THREE LEVEL 50 MM PLATE | In distribution |
| 83472E | FOUR LEVEL 72 MM PLATE | In distribution |
| 83346E | THREE LEVEL 46 MM PLATE | In distribution |
| 83352E | THREE LEVEL 52 MM PLATE | In distribution |
| 63058E | 5.0 MM X 20 MM BONE SCREW | In distribution |
| 83228E | TWO LEVEL 28 MM PLATE | In distribution |
| 83460E | FOUR LEVEL 60 MM PLATE | In distribution |
| 83116E | ONE LEVEL 16 MM PLATE | In distribution |
| 63025E | 4.0 MM X 12 MM BONE SCREW | In distribution |
| 83362E | THREE LEVEL 62 MM PLATE | In distribution |
| 63035E | 4.0 MM X 22 MM BONE SCREW | In distribution |
| 63056E | 5.0 MM X 18 MM BONE SCREW | In distribution |
| 63051E | 5.0 MM X 12 MM SELF DRILLING BONE SCREW | In distribution |
| 63030E | 4 MM X 16 MM SELF DRILLING BONE SCREW | In distribution |
| 83238E | TWO LEVEL 38 MM PLATE | In distribution |
| 63031E | 4.0 MM X 18 MM BONE SCREW | In distribution |
| 83112E | ONE LEVEL 12 MM PLATE | In distribution |
| 83226E | TWO LEVEL 26 MM PLATE | In distribution |
| 63037E | 4.0 MM X 24 MM BONE SCREW | In distribution |
| 83464E | FOUR LEVEL 64 MM PLATE | In distribution |
| 83236E | TWO LEVEL 36 MM PLATE | In distribution |
| 63033E | 4.0 MM X 20 MM BONE SCREW | In distribution |
| 83358E | THREE LEVEL 58 MM PLATE | In distribution |
| 83484E | FOUR LEVEL 84 MM PLATE | In distribution |
| 83348E | THREE LEVEL 48 MM PLATE | In distribution |
| 83124E | ONE LEVEL 24 MM PLATE | In distribution |
| 63029E | 4.0 MM X 16 MM BONE SCREW | In distribution |
| 83360E | THREE LEVEL 60 MM PLATE | In distribution |
| 63054E | 5.0 MM X 16 MM BONE SCREW | In distribution |
| 63053E | 5.0 MM X 14 MM SELF DRILLING BONE SCREW | In distribution |
| 83492E | FOUR LEVEL 92 MM PLATE | In distribution |
| 83480E | FOUR LEVEL 80 MM PLATE | In distribution |
| 63062E | 5.0 MM X 24 MM BONE SCREW | In distribution |
| 63024E | 4 MM X 12 MM SELF DRILLING BONE SCREW | In distribution |
| 63060E | 5.0 MM X 22 MM BONE SCREW | In distribution |
| 63052E | 5.0 MM X 14 MM BONE SCREW | In distribution |
| 83488E | FOUR LEVEL 88 MM PLATE | In distribution |
| 83230E | TWO LEVEL 30 MM PLATE | In distribution |
| 83354E | THREE LEVEL 54 MM PLATE | In distribution |
| 83240E | TWO LEVEL 40 MM PLATE | In distribution |
| 63028E | 4 MM X 14 MM SELF DRILLING BONE SCREW | In distribution |
| 83366E | THREE LEVEL 66 MM PLATE | In distribution |
| 63055E | 5.0 MM X 16 MM SELF DRILLING BONE SCREW | In distribution |
| 83118E | ONE LEVEL 18 MM PLATE | In distribution |
| 83120E | ONE LEVEL 20 MM PLATE | In distribution |
| 83364E | THREE LEVEL 64 MM PLATE | 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 |
|---|---|
| K103393 | 2011-02-02 |
| K080646 | 2008-05-02 |
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.