Fuji Cervical Plate System
Cortical-Cancellous Variable Angle Self-Drilling Screw, 4.0mm Diameter x Length 20mm
14manufacturers in China registered for this device type
157catalogue 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 | Altus 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) | K163061 |
| Record published | 2017-08-22 |
| Record revised | 2024-09-11 (version 6) |
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, manufacturing date |
| Sizes | Length 12 to 89 mm; outer diameter 4 to 4.35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 114-0362 | Length 62 mm | In distribution |
| 138-4018 | Outer Diameter 4 mm | In distribution |
| 137-4016 | Length 16 mm | In distribution |
| 111-4316 | Length 16 mm | In distribution |
| 100-1010 | In distribution | |
| 122-4016 | Length 16 mm | In distribution |
| 112-4314 | Outer Diameter 4.35 mm | In distribution |
| 122-4320 | Length 20 mm | In distribution |
| 138-4313 | Outer Diameter 4.35 mm | In distribution |
| 114-0480 | Length 80 mm | In distribution |
| 114-0250 | Length 50 mm | In distribution |
| 112-4020 | Length 20 mm | In distribution |
| 114-0483 | Length 83 mm | In distribution |
| 100-1034 | In distribution | |
| 139-4015 | Outer Diameter 4 mm | In distribution |
| 121-4313 | Outer Diameter 4.35 mm | In distribution |
| 114-0134 | Length 34 mm | In distribution |
| 121-4315 | Outer Diameter 4.35 mm | In distribution |
| 136-4312 | Length 12 mm | In distribution |
| 111-4322 | Outer Diameter 4.35 mm | In distribution |
| 111-4016 | Outer Diameter 4 mm | In distribution |
| 137-4020 | Outer Diameter 4 mm | In distribution |
| 137-4312 | Length 12 mm | In distribution |
| 138-4014 | Length 14 mm | In distribution |
| 121-4318 | Length 18 mm | In distribution |
| 114-0244 | Length 44 mm | In distribution |
| 114-0130 | Length 30 mm | In distribution |
| 111-4020 | Outer Diameter 4 mm | In distribution |
| 122-4312 | Outer Diameter 4.35 mm | In distribution |
| 136-4016 | Outer Diameter 4 mm | In distribution |
| 138-4015 | Length 15 mm | In distribution |
| 139-4013 | Length 13 mm | In distribution |
| 138-4322 | Outer Diameter 4.35 mm | In distribution |
| 100-1035 | In distribution | |
| 139-4020 | Length 20 mm | In distribution |
| 122-4314 | Length 14 mm | In distribution |
| 138-4012 | Length 12 mm | In distribution |
| 114-0356 | Length 56 mm | In distribution |
| 111-4320 | Length 20 mm | In distribution |
| 114-0238 | Length 38 mm | In distribution |
| 136-4314 | Length 14 mm | In distribution |
| 114-0347 | Length 47 mm | In distribution |
| 114-0124 | Length 24 mm | In distribution |
| 121-4012 | Length 12 mm | In distribution |
| 100-1114 | In distribution | |
| 100-1030 | In distribution | |
| 111-4315 | Length 15 mm | In distribution |
| 111-4014 | Length 14 mm | In distribution |
| 137-4014 | Length 14 mm | In distribution |
| 122-4012 | Outer Diameter 4 mm | In distribution |
| 114-0126 | Length 26 mm | In distribution |
| 114-0120 | Length 20 mm | In distribution |
| 112-4316 | Outer Diameter 4.35 mm | In distribution |
| 122-4013 | Outer Diameter 4 mm | In distribution |
| 111-4313 | Outer Diameter 4.35 mm | In distribution |
| 121-4018 | Length 18 mm | In distribution |
| 136-4322 | Length 22 mm | In distribution |
| 121-4320 | Length 20 mm | In distribution |
| 111-4314 | Outer Diameter 4.35 mm | In distribution |
| 114-0241 | Length 41 mm | In distribution |
| 100-3101 | In distribution | |
| 121-4016 | Outer Diameter 4 mm | In distribution |
| 121-4022 | Outer Diameter 4 mm | In distribution |
| 114-0359 | Length 59 mm | In distribution |
| 137-4018 | Outer Diameter 4 mm | In distribution |
| 137-4022 | Length 22 mm | In distribution |
| 138-4020 | Outer Diameter 4 mm | In distribution |
| 137-4316 | Length 16 mm | In distribution |
| 114-0477 | Length 77 mm | In distribution |
| 114-0128 | Length 28 mm | In distribution |
| 122-4015 | Outer Diameter 4 mm | In distribution |
| 136-4318 | Length 18 mm | In distribution |
| 100-2026 | In distribution | |
| 121-4322 | Outer Diameter 4.35 mm | In distribution |
| 137-4314 | Outer Diameter 4.35 mm | In distribution |
| 139-4012 | Outer Diameter 4 mm | In distribution |
| 112-4014 | Length 14 mm | In distribution |
| 100-3100 | In distribution | |
| 112-4018 | Length 18 mm | In distribution |
| 112-4013 | Outer Diameter 4 mm | In distribution |
| 138-4315 | Outer Diameter 4.35 mm | In distribution |
| 100-2028 | In distribution | |
| 111-4012 | Length 12 mm | In distribution |
| 114-0474 | Length 74 mm | In distribution |
| 138-4314 | Outer Diameter 4.35 mm | In distribution |
| 114-0471 | Length 71 mm | In distribution |
| 111-4318 | Length 18 mm | In distribution |
| 121-4015 | Outer Diameter 4 mm | In distribution |
| 114-0232 | Length 32 mm | In distribution |
| 139-4016 | Outer Diameter 4 mm | In distribution |
| 138-4316 | Length 16 mm | In distribution |
| 111-4013 | Length 13 mm | In distribution |
| 100-1002 | In distribution | |
| 114-0489 | Length 89 mm | In distribution |
| 111-4022 | Length 22 mm | In distribution |
| 136-4020 | Outer Diameter 4 mm | In distribution |
| 114-0230 | Length 30 mm | In distribution |
| 111-4312 | Length 12 mm | In distribution |
| 112-4015 | Length 15 mm | In distribution |
| 100-1116 | In distribution | |
| 114-0486 | Length 86 mm | In distribution |
| 114-0247 | Length 47 mm | In distribution |
| 121-4020 | Outer Diameter 4 mm | In distribution |
| 100-1018 | In distribution | |
| 122-4316 | Length 16 mm | In distribution |
| 139-4014 | Length 14 mm | In distribution |
| 112-4312 | Length 12 mm | In distribution |
| 114-0350 | Length 50 mm | In distribution |
| 138-4016 | Outer Diameter 4 mm | In distribution |
| 100-2001 | In distribution | |
| 122-4018 | Length 18 mm | In distribution |
| 114-0368 | Length 68 mm | In distribution |
| 112-4022 | Length 22 mm | In distribution |
| 139-4018 | Outer Diameter 4 mm | In distribution |
| 139-4022 | Length 22 mm | In distribution |
| 121-4014 | Length 14 mm | In distribution |
| 122-4014 | Outer Diameter 4 mm | In distribution |
| 121-4312 | Length 12 mm | In distribution |
| 114-0353 | Length 53 mm | In distribution |
| 136-4014 | Length 14 mm | In distribution |
| 122-4020 | Length 20 mm | In distribution |
| 100-2027 | In distribution | |
| 111-4018 | Outer Diameter 4 mm | In distribution |
| 122-4318 | Outer Diameter 4.35 mm | In distribution |
| 111-4015 | Outer Diameter 4 mm | In distribution |
| 114-0374 | Length 74 mm | In distribution |
| 136-4320 | Outer Diameter 4.35 mm | In distribution |
| 112-4318 | Outer Diameter 4.35 mm | In distribution |
| 138-4013 | Outer Diameter 4 mm | In distribution |
| 137-4012 | Length 12 mm | In distribution |
| 114-0377 | Length 77 mm | In distribution |
| 136-4316 | Length 16 mm | In distribution |
| 114-0365 | Length 65 mm | In distribution |
| 136-4018 | Length 18 mm | In distribution |
| 112-4012 | Length 12 mm | In distribution |
| 121-4013 | Outer Diameter 4 mm | In distribution |
| 121-4314 | Length 14 mm | In distribution |
| 114-0118 | Length 18 mm | In distribution |
| 121-4316 | Outer Diameter 4.35 mm | In distribution |
| 112-4016 | Length 16 mm | In distribution |
| 114-0235 | Length 35 mm | In distribution |
| 136-4012 | Outer Diameter 4 mm | In distribution |
| 114-0136 | Length 36 mm | In distribution |
| 138-4312 | Length 12 mm | In distribution |
| 114-0122 | Length 22 mm | In distribution |
| 122-4022 | Length 22 mm | In distribution |
| 100-1024 | In distribution | |
| 114-0256 | Length 56 mm | In distribution |
| 138-4320 | Outer Diameter 4.35 mm | In distribution |
| 136-4022 | Outer Diameter 4 mm | In distribution |
| 114-0371 | Length 71 mm | In distribution |
| 137-4318 | Outer Diameter 4.35 mm | In distribution |
| 138-4318 | Length 18 mm | In distribution |
| 138-4022 | Outer Diameter 4 mm | In distribution |
| 114-0253 | Length 53 mm | In distribution |
| 114-0132 | Length 32 mm | In distribution |
| 100-1112 | 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.