Kasilof Cervical Plate System
KASILOF VA Self-Drilling Screw 4.5 x 16mm
14manufacturers in China registered for this device type
59catalogue numbers in this listing
1510(k) clearance
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 | Kahtnu Surgical, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K173867 |
| Record published | 2018-09-01 |
| Record revised | 2025-07-02 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KCP1-440-016 | In distribution | |
| KCP1-540-018 | In distribution | |
| KCP1-490 | In distribution | |
| KCP1-131 | In distribution | |
| KCP1-135 | In distribution | |
| KCP1-123 | In distribution | |
| KCP1-366 | In distribution | |
| KCP1-378 | In distribution | |
| KCP1-5105 | In distribution | |
| KCP1-440-010 | In distribution | |
| KCP1-235 | In distribution | |
| KCP1-133 | In distribution | |
| KCP1-5100 | In distribution | |
| KCP1-481 | In distribution | |
| KCP1-121 | In distribution | |
| KCP1-369 | In distribution | |
| KCP1-241 | In distribution | |
| KCP1-357 | In distribution | |
| KCP1-440-012 | In distribution | |
| KCP1-245 | In distribution | |
| KCP1-360 | In distribution | |
| KCP1-251 | In distribution | |
| KCP1-545-116 | In distribution | |
| KCP1-129 | In distribution | |
| KCP1-540-110 | In distribution | |
| KCP1-375 | In distribution | |
| KCP1-440-014 | In distribution | |
| KCP1-484 | In distribution | |
| KCP1-540-114 | In distribution | |
| KCP1-545-112 | In distribution | |
| KCP1-249 | In distribution | |
| KCP1-540-118 | In distribution | |
| KCP1-127 | In distribution | |
| KCP1-545-118 | In distribution | |
| KCP1-540-010 | In distribution | |
| KCP1-372 | In distribution | |
| KCP1-354 | In distribution | |
| KCP1-540-014 | In distribution | |
| KCP1-540-016 | In distribution | |
| KCP1-255 | In distribution | |
| KCP1-247 | In distribution | |
| KCP1-5095 | In distribution | |
| KCP1-5110 | In distribution | |
| KCP1-540-116 | In distribution | |
| KCP1-239 | In distribution | |
| KCP1-253 | In distribution | |
| KCP1-540-012 | In distribution | |
| KCP1-540-112 | In distribution | |
| KCP1-440-018 | In distribution | |
| KCP1-478 | In distribution | |
| KCP1-487 | In distribution | |
| KCP1-545-114 | In distribution | |
| KCP1-545-110 | In distribution | |
| KCP1-237 | In distribution | |
| KCP1-363 | In distribution | |
| KCP1-5090 | In distribution | |
| KCP1-243 | In distribution | |
| KCP1-119 | In distribution | |
| KCP1-125 | 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 |
|---|---|
| K203154 | 2020-11-05 |
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.