Defender™ Anterior Cervical Plate System
Variable Self-Drilling Screw, ø4.35 mm X 14 mm
14manufacturers in China registered for this device type
89catalogue 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 | Spine Wave, 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, Manufacturer |
| 510(k) | K182489 |
| Record published | 2021-08-05 |
| Record revised | 2024-09-11 (version 4) |
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 | Outer diameter 4 to 4.35 mm; length 10 to 22 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-5620 | Outer Diameter 4.0 mm | In distribution |
| 15-5734 | Outer Diameter 4.35 mm | In distribution |
| 15-5622 | Outer Diameter 4.0 mm | In distribution |
| 15-5634 | Outer Diameter 4.35 mm | In distribution |
| 15-5345 | In distribution | |
| 15-5363 | In distribution | |
| 15-5932 | Outer Diameter 4.35 mm | In distribution |
| 15-5576 | In distribution | |
| 15-5614 | Outer Diameter 4.0 mm | In distribution |
| 15-5736 | Outer Diameter 4.35 mm | In distribution |
| 15-5228 | In distribution | |
| 15-5936 | Outer Diameter 4.35 mm | In distribution |
| 15-5834 | Outer Diameter 4.35 mm | In distribution |
| 15-5242 | In distribution | |
| 15-5222 | In distribution | |
| 15-5912 | Outer Diameter 4.0 mm | In distribution |
| 15-5348 | In distribution | |
| 15-5816 | Outer Diameter 4.0 mm | In distribution |
| 15-5586 | In distribution | |
| 15-5366 | In distribution | |
| 15-5224 | In distribution | |
| 15-5640 | Outer Diameter 4.35 mm | In distribution |
| 15-5642 | Outer Diameter 4.35 mm | In distribution |
| 15-5818 | Outer Diameter 4.0 mm | In distribution |
| 15-5450 | In distribution | |
| 15-5712 | Outer Diameter 4.0 mm | In distribution |
| 15-5108 | In distribution | |
| 15-5714 | Outer Diameter 4.0 mm | In distribution |
| 15-5230 | In distribution | |
| 15-5632 | Outer Diameter 4.35 mm | In distribution |
| 15-5454 | In distribution | |
| 15-5238 | In distribution | |
| 15-5838 | Outer Diameter 4.35 mm | In distribution |
| 15-5466 | In distribution | |
| 15-5246 | In distribution | |
| 15-5716 | Outer Diameter 4.0 mm | In distribution |
| 15-5226 | In distribution | |
| 15-5812 | Outer Diameter 4.0 mm | In distribution |
| 15-5840 | Outer Diameter 4.35 mm | In distribution |
| 15-5591 | In distribution | |
| 15-5810 | Outer Diameter 4.0 mm | In distribution |
| 15-5126 | In distribution | |
| 15-5836 | Outer Diameter 4.35 mm | In distribution |
| 15-5122 | In distribution | |
| 15-5234 | In distribution | |
| 15-5339 | In distribution | |
| 15-5462 | In distribution | |
| 15-5612 | Outer Diameter 4.0 mm | In distribution |
| 15-5360 | In distribution | |
| 15-5842 | Outer Diameter 4.35 mm | In distribution |
| 15-5638 | Outer Diameter 4.35 mm | In distribution |
| 15-5916 | Outer Diameter 4.0 mm | In distribution |
| 15-5618 | Outer Diameter 4.0 mm | In distribution |
| 15-5478 | In distribution | |
| 15-5369 | In distribution | |
| 15-5474 | In distribution | |
| 15-5822 | Outer Diameter 4.0 mm | In distribution |
| 15-5814 | Outer Diameter 4.0 mm | In distribution |
| 15-5124 | In distribution | |
| 15-5581 | In distribution | |
| 15-5616 | Outer Diameter 4.0 mm | In distribution |
| 15-5351 | In distribution | |
| 15-5232 | In distribution | |
| 15-5914 | Outer Diameter 4.0 mm | In distribution |
| 15-5934 | Outer Diameter 4.35 mm | In distribution |
| 15-5446 | In distribution | |
| 15-5354 | In distribution | |
| 15-5240 | In distribution | |
| 15-5116 | In distribution | |
| 15-5636 | Outer Diameter 4.35 mm | In distribution |
| 15-5244 | In distribution | |
| 15-5610 | Outer Diameter 4.0 mm | In distribution |
| 15-5458 | In distribution | |
| 15-5732 | Outer Diameter 4.35 mm | In distribution |
| 15-5342 | In distribution | |
| 15-5120 | In distribution | |
| 15-5820 | Outer Diameter 4.0 mm | In distribution |
| 15-5118 | In distribution | |
| 15-5830 | Outer Diameter 4.35 mm | In distribution |
| 15-5110 | In distribution | |
| 15-5571 | In distribution | |
| 15-5357 | In distribution | |
| 15-5832 | Outer Diameter 4.35 mm | In distribution |
| 15-5112 | In distribution | |
| 15-5630 | Outer Diameter 4.35 mm | In distribution |
| 15-5236 | In distribution | |
| 15-5336 | In distribution | |
| 15-5470 | In distribution | |
| 15-5114 | 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.