King Cobra
King Cobra is an anterior cervical plate system used as an adjunct to spinal fusion from C2 to C7. Plates and self-tapping screws form a fixation construct that stabilizes the cervical…
King Cobra is an anterior cervical plate system used as an adjunct to spinal fusion from C2 to C7. Plates and self-tapping screws form a fixation construct that stabilizes the cervical spine during treatment.
Both plates and screws are made from Ti-6Al-4V titanium alloy. Plates are offered in different lengths, while screws come in multiple combinations of diameter and length to suit the planned fixation.
Conditions Treated
The system is intended for degenerative disc disease, spondylolisthesis, fractures or dislocations, spinal stenosis, deformity, tumor, pseudarthrosis and failed previous fusion. Degenerative disc disease means neck pain of disc origin with degeneration confirmed by history and imaging.
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 | Eminent Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K103068 |
| Record published | 2017-02-09 |
| Record revised | 2025-07-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KCP623 | In distribution | |
| KCP181 | In distribution | |
| KCP4114 | In distribution | |
| KCP4314 | In distribution | |
| KCP161 | In distribution | |
| KCP764 | In distribution | |
| KCP864 | In distribution | |
| KCP201 | In distribution | |
| KCP563 | In distribution | |
| KCP362 | In distribution | |
| KCP4014 | In distribution | |
| KCP4012 | In distribution | |
| KCP604 | In distribution | |
| KCP261 | In distribution | |
| KCP644 | In distribution | |
| KCP473 | In distribution | |
| KCP221 | In distribution | |
| KCP302 | In distribution | |
| KCP503 | In distribution | |
| KCP4112 | In distribution | |
| KCP724 | In distribution | |
| KCP241 | In distribution | |
| KCP683 | In distribution | |
| KCP4216 | In distribution | |
| KCP713 | In distribution | |
| KCP282 | In distribution | |
| KCP4016 | In distribution | |
| KCP653 | In distribution | |
| KCP593 | In distribution | |
| KCP332 | In distribution | |
| KCP452 | In distribution | |
| KCP4116 | In distribution | |
| KCP4214 | In distribution | |
| KCP844 | In distribution | |
| KCP482 | In distribution | |
| KCP392 | In distribution | |
| KCP4212 | In distribution | |
| KCP422 | In distribution | |
| KCP4316 | In distribution | |
| KCP281 | In distribution | |
| KCP804 | In distribution | |
| KCP141 | In distribution | |
| KCP533 | In distribution | |
| KCP4312 | 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 |
|---|---|
| K201979 | 2020-08-25 |
| K133194 | 2014-06-26 |
| K103068 | 2011-01-14 |
| K090415 | 2009-06-01 |
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.