Accufuse Cervical System
Cervical Plate Cover 1 Level Plate 11-12
14manufacturers in China registered for this device type
100catalogue 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 | Absolute Advantage Medical, LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2019-04-15 |
| Record revised | 2022-09-16 (version 6) |
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, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-20-01 | In distribution | |
| 1P11P12 | In distribution | |
| FB4018 | In distribution | |
| 10-16 | In distribution | |
| 10-17-11 | In distribution | |
| VS4018 | In distribution | |
| VB4512 | In distribution | |
| VB4020 | In distribution | |
| 2P44 | In distribution | |
| 10-04 | In distribution | |
| 1P10C8 | In distribution | |
| 10-03-14 | In distribution | |
| FS4018 | In distribution | |
| 10-17-12 | In distribution | |
| 1P14C12 | In distribution | |
| FB4520 | In distribution | |
| FB4514 | In distribution | |
| 10-11-13 | In distribution | |
| FS4516 | In distribution | |
| 2P29P32 | In distribution | |
| VB4016 | In distribution | |
| 2P35 | In distribution | |
| 1P9C7 | In distribution | |
| 10-17-10 | In distribution | |
| 10-20-02 | In distribution | |
| FB4016 | In distribution | |
| 1P11C9 | In distribution | |
| FS4518 | In distribution | |
| VB4514 | In distribution | |
| FS4512 | In distribution | |
| FS4020 | In distribution | |
| 1P7P8 | In distribution | |
| VS4514 | In distribution | |
| 1P7C5 | In distribution | |
| 10-05 | In distribution | |
| VB4516 | In distribution | |
| 1P12C10 | In distribution | |
| FS4016 | In distribution | |
| 10-11-10 | In distribution | |
| VB4014 | In distribution | |
| 1P13P14 | In distribution | |
| 2P26 | In distribution | |
| 10-20-06 | In distribution | |
| 10-15 | In distribution | |
| VS4016 | In distribution | |
| 1P8C6 | In distribution | |
| FB4516 | In distribution | |
| 2P23 | In distribution | |
| FB4020 | In distribution | |
| 2P23P26 | In distribution | |
| 10-11-09 | In distribution | |
| FB4014 | In distribution | |
| 10-17-09 | In distribution | |
| 10-03-12 | In distribution | |
| FS4012 | In distribution | |
| 10-06 | In distribution | |
| 1P13C11 | In distribution | |
| 10-20 | In distribution | |
| FB4518 | In distribution | |
| VS4012 | In distribution | |
| VS4020 | In distribution | |
| VB4518 | In distribution | |
| VB4018 | In distribution | |
| 10-07 | In distribution | |
| 2P29 | In distribution | |
| 2P41P44 | In distribution | |
| 10-17-08 | In distribution | |
| FS4520 | In distribution | |
| 10-20-03 | In distribution | |
| FS4014 | In distribution | |
| 10-20-05 | In distribution | |
| 10-14 | In distribution | |
| VS4516 | In distribution | |
| 10-03-16 | In distribution | |
| 10-17-06 | In distribution | |
| 1P9P10 | In distribution | |
| VB4012 | In distribution | |
| VS4014 | In distribution | |
| 10-11-14 | In distribution | |
| 10-11-12 | In distribution | |
| VS4520 | In distribution | |
| 2P41 | In distribution | |
| VB4520 | In distribution | |
| FB4512 | In distribution | |
| FB4012 | In distribution | |
| FS4514 | In distribution | |
| 10-11-11 | In distribution | |
| 10-09 | In distribution | |
| VS4518 | In distribution | |
| VS4512 | In distribution | |
| 10-10 | In distribution | |
| 10-17-07 | In distribution | |
| 10-11-07 | In distribution | |
| 10-11-08 | In distribution | |
| 10-02 | In distribution | |
| 2P32 | In distribution | |
| 2P35P38 | In distribution | |
| 10-17-05 | In distribution | |
| 2P38 | In distribution | |
| 10-20-07 | 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.