Cervalign
Cervalign, VST, 4.0MM, 10MM
14manufacturers in China registered for this device type
73catalogue numbers in this listing
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 | Xtant Medical Holdings, Inc., 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) | K211408 |
| Record published | 2023-06-09 |
| Record revised | 2025-04-08 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 66-VST-40-10 | In distribution | |
| 66-VST-40-14 | In distribution | |
| 66-238 | In distribution | |
| 66-FST-40-12 | In distribution | |
| 66-488 | In distribution | |
| 66-FST-45-18 | In distribution | |
| 66-590 | In distribution | |
| 66-460 | In distribution | |
| 66-VST-45-18 | In distribution | |
| 66-5105 | In distribution | |
| 66-FST-40-18 | In distribution | |
| 66-240 | In distribution | |
| 66-363 | In distribution | |
| 66-345 | In distribution | |
| 66-FST-45-14 | In distribution | |
| 66-FSD-40-16 | In distribution | |
| 66-VST-40-12 | In distribution | |
| 66-VSD-40-10 | In distribution | |
| 66-FSD-40-10 | In distribution | |
| 66-FST-40-14 | In distribution | |
| 66-FSD-40-14 | In distribution | |
| 66-234 | In distribution | |
| 66-354 | In distribution | |
| 66-224 | In distribution | |
| 66-110 | In distribution | |
| 66-FST-45-16 | In distribution | |
| 66-5100 | In distribution | |
| 66-468 | In distribution | |
| 66-FST-45-10 | In distribution | |
| 66-472 | In distribution | |
| 66-VSD-40-14 | In distribution | |
| 66-480 | In distribution | |
| 66-122 | In distribution | |
| 66-FST-40-20 | In distribution | |
| 66-VST-40-16 | In distribution | |
| 66-348 | In distribution | |
| 66-VSD-40-16 | In distribution | |
| 66-351 | In distribution | |
| 66-228 | In distribution | |
| 66-236 | In distribution | |
| 66-360 | In distribution | |
| 66-FST-45-12 | In distribution | |
| 66-114 | In distribution | |
| 66-VST-45-10 | In distribution | |
| 66-VSD-40-12 | In distribution | |
| 66-FST-40-10 | In distribution | |
| 66-580 | In distribution | |
| 66-116 | In distribution | |
| 66-FST-45-20 | In distribution | |
| 66-118 | In distribution | |
| 66-VST-45-12 | In distribution | |
| 66-FSD-40-12 | In distribution | |
| 66-VST-40-20 | In distribution | |
| 66-464 | In distribution | |
| 66-VST-40-18 | In distribution | |
| 66-124 | In distribution | |
| 66-232 | In distribution | |
| 66-230 | In distribution | |
| 66-357 | In distribution | |
| 66-575 | In distribution | |
| 66-484 | In distribution | |
| 66-VST-45-20 | In distribution | |
| 66-595 | In distribution | |
| 66-242 | In distribution | |
| 66-VST-45-16 | In distribution | |
| 66-476 | In distribution | |
| 66-VST-45-14 | In distribution | |
| 66-226 | In distribution | |
| 66-342 | In distribution | |
| 66-112 | In distribution | |
| 66-FST-40-16 | In distribution | |
| 66-585 | In distribution | |
| 66-120 | 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
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.