4CIS® Pinehurst Anterior Cervical Plate System
4CIS® Pinehurst Variable Self Drilling Screw ø3.5 X 10mm
14manufacturers in China registered for this device type
177catalogue 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 | Alpha AI Co., Ltd., South Korea |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer |
| 510(k) | K182489 |
| Record published | 2019-01-24 |
| Record revised | 2026-01-19 (version 8) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8207-3515 | In distribution | |
| 5932-1121 | In distribution | |
| 8206-3519 | In distribution | |
| 8013-0586 | In distribution | |
| 8013-0116 | In distribution | |
| 8013-0462 | In distribution | |
| 15-8640 | In distribution | |
| 8013-0126 | In distribution | |
| 8013-0110 | In distribution | |
| 8206-4014 | In distribution | |
| 8208-3510 | In distribution | |
| 8207-3518 | In distribution | |
| 15-8620 | In distribution | |
| 8208-3513 | In distribution | |
| 8013-0576 | In distribution | |
| 8013-0120 | In distribution | |
| 8209-3515 | In distribution | |
| 8209-4011 | In distribution | |
| 8013-0228 | In distribution | |
| 8013-0232 | In distribution | |
| 8209-4016 | In distribution | |
| 8209-3519 | In distribution | |
| 8206-4022 | In distribution | |
| 15-8812 | In distribution | |
| 15-8610 | In distribution | |
| 8013-0458 | In distribution | |
| 8207-4019 | In distribution | |
| 15-8642 | In distribution | |
| 8209-3518 | In distribution | |
| 8209-4014 | In distribution | |
| 8207-3520 | In distribution | |
| 15-8632 | In distribution | |
| 8208-3522 | In distribution | |
| 15-8814 | In distribution | |
| 8013-0591 | In distribution | |
| 8207-3513 | In distribution | |
| 15-8612 | In distribution | |
| 8013-0222 | In distribution | |
| 8209-3516 | In distribution | |
| 8208-4020 | In distribution | |
| 8207-4017 | In distribution | |
| 8013-0581 | In distribution | |
| 8013-0354 | In distribution | |
| 8208-3520 | In distribution | |
| 8207-4016 | In distribution | |
| 8209-3517 | In distribution | |
| 8013-0118 | In distribution | |
| 8206-3511 | In distribution | |
| 8013-0345 | In distribution | |
| 8208-4019 | In distribution | |
| 8013-0474 | In distribution | |
| 8208-4016 | In distribution | |
| 8207-4011 | In distribution | |
| 8206-4010 | In distribution | |
| 8207-4015 | In distribution | |
| 8207-4010 | In distribution | |
| 8013-0366 | In distribution | |
| 8013-0369 | In distribution | |
| 15-8838 | In distribution | |
| 8206-3514 | In distribution | |
| 8209-4019 | In distribution | |
| 8207-4022 | In distribution | |
| 8208-4015 | In distribution | |
| 15-8636 | In distribution | |
| 8208-4013 | In distribution | |
| 8013-0230 | In distribution | |
| 8209-4022 | In distribution | |
| 5932-1111 | In distribution | |
| 8013-0240 | In distribution | |
| 8209-3510 | In distribution | |
| 8013-0351 | In distribution | |
| 8208-3515 | In distribution | |
| 15-8822 | In distribution | |
| 8013-0336 | In distribution | |
| 8207-3522 | In distribution | |
| 8013-0112 | In distribution | |
| 8207-3512 | In distribution | |
| 8209-4013 | In distribution | |
| 15-8842 | In distribution | |
| 8013-0470 | In distribution | |
| 8206-4016 | In distribution | |
| 8206-3518 | In distribution | |
| 8013-0357 | In distribution | |
| 15-8840 | In distribution | |
| 8206-3515 | In distribution | |
| 8206-3513 | In distribution | |
| 8209-4017 | In distribution | |
| 8207-3511 | In distribution | |
| 5932-1122 | In distribution | |
| 8207-3516 | In distribution | |
| 8206-4020 | In distribution | |
| 8208-4014 | In distribution | |
| 8207-4013 | In distribution | |
| 8208-4012 | In distribution | |
| 8207-4014 | In distribution | |
| 8209-3514 | In distribution | |
| 8208-3512 | In distribution | |
| 8013-0226 | In distribution | |
| 8209-3522 | In distribution | |
| 8207-3510 | In distribution | |
| 15-8830 | In distribution | |
| 8208-4018 | In distribution | |
| 8013-0339 | In distribution | |
| 15-8618 | In distribution | |
| 8206-3522 | In distribution | |
| 8013-0446 | In distribution | |
| 8206-3520 | In distribution | |
| 8013-0363 | In distribution | |
| 8206-4012 | In distribution | |
| 8206-3517 | In distribution | |
| 8013-0236 | In distribution | |
| 15-8622 | In distribution | |
| 8013-0246 | In distribution | |
| 15-8614 | In distribution | |
| 8013-0124 | In distribution | |
| 8208-4010 | In distribution | |
| 5932-1112 | In distribution | |
| 8209-3513 | In distribution | |
| 8206-3516 | In distribution | |
| 8209-4020 | In distribution | |
| 8013-0360 | In distribution | |
| 15-8630 | In distribution | |
| 8208-4022 | In distribution | |
| 8208-3517 | In distribution | |
| 8013-0244 | In distribution | |
| 8208-4011 | In distribution | |
| 8013-0234 | In distribution | |
| 8206-4013 | In distribution | |
| 15-8820 | In distribution | |
| 8208-4017 | In distribution | |
| 8208-3519 | In distribution | |
| 15-8818 | In distribution | |
| 15-8836 | In distribution | |
| 8208-3516 | In distribution | |
| 8013-0122 | In distribution | |
| 15-8634 | In distribution | |
| 8206-4015 | In distribution | |
| 8013-0478 | In distribution | |
| 8209-4010 | In distribution | |
| 15-8832 | In distribution | |
| 8013-0108 | In distribution | |
| 8207-4012 | In distribution | |
| 8209-4015 | In distribution | |
| 8207-3519 | In distribution | |
| 8206-4019 | In distribution | |
| 8209-3512 | In distribution | |
| 8209-4018 | In distribution | |
| 8206-4011 | In distribution | |
| 8013-0114 | In distribution | |
| 8208-3511 | In distribution | |
| 8207-4020 | In distribution | |
| 15-8616 | In distribution | |
| 8206-3510 | In distribution | |
| 15-8638 | In distribution | |
| 8013-0571 | In distribution | |
| 8207-3514 | In distribution | |
| 8206-4017 | In distribution | |
| 8207-4018 | In distribution | |
| 8208-3514 | In distribution | |
| 15-8816 | In distribution | |
| 8209-3520 | In distribution | |
| 8013-0466 | In distribution | |
| 8013-0454 | In distribution | |
| 15-8810 | In distribution | |
| 8206-3512 | In distribution | |
| 8209-3511 | In distribution | |
| 8013-0450 | In distribution | |
| 8206-4018 | In distribution | |
| 8013-0238 | In distribution | |
| 8207-3517 | In distribution | |
| 8209-4012 | In distribution | |
| 8013-0224 | In distribution | |
| 8208-3518 | In distribution | |
| 15-8834 | In distribution | |
| 8013-0348 | In distribution | |
| 8013-0342 | In distribution | |
| 8013-0242 | 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.