VAN Gogh Anterior Cervical Plate System

VAN GOGH Cervical Plate, 1 Level, LX, 12mm, X-Lordotic

Registry build 21.09.26
14manufacturers in China registered for this device type
187catalogue numbers in this listing
2510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code KWQ
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

Regulatory record for VAN Gogh Anterior Cervical Plate System
Listed by CTL Medical Corporation, 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, Complaint-file establishment, Manufacturer
510(k) K121078
Record published 2016-03-02
Record revised 2025-12-02 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for VAN Gogh Anterior Cervical Plate System
Catalogue number Size Status
011.7142 In distribution
011.4063 In distribution
011.0436 In distribution
011.3057 In distribution
011.0413 In distribution
011.0667 In distribution
011.0618 In distribution
011.8710 In distribution
011.5089 In distribution
011.2028 In distribution
011.0466 In distribution
011.0260 In distribution
011.0663 In distribution
011.0416 In distribution
011.7112 In distribution
011.1016 In distribution
011.0288 In distribution
011.5083 In distribution
011.2126 In distribution
011.0860 In distribution
011.0669 In distribution
011.1162 In distribution
011.0815 In distribution
011.0610 In distribution
011.0661 In distribution
011.0268 In distribution
011.0215 In distribution
011.0463 In distribution
011.5086 In distribution
011.8114 In distribution
011.0234 In distribution
011.0868 In distribution
011.0832 In distribution
011.2042 In distribution
011.0834 In distribution
011.0412 In distribution
011.5098 In distribution
011.0282 In distribution
011.0812 In distribution
011.2036 In distribution
011.0217 In distribution
011.3051 In distribution
011.2032 In distribution
011.3042 In distribution
011.0417 In distribution
011.0864 In distribution
011.0211 In distribution
011.0870 In distribution
011.0838 In distribution
011.0232 In distribution
011.2046 In distribution
011.0269 In distribution
011.0216 In distribution
011.0286 In distribution
011.4072 In distribution
011.4069 In distribution
011.0670 In distribution
011.2030 In distribution
011.0818 In distribution
011.0236 In distribution
011.0617 In distribution
011.7182 In distribution
011.1064 In distribution
011.0486 In distribution
011.0862 In distribution
011.0210 In distribution
011.0462 In distribution
011.1012 In distribution
011.0411 In distribution
011.0482 In distribution
011.0660 In distribution
011.0465 In distribution
011.4066 In distribution
011.0620 In distribution
011.7121 In distribution
011.5104 In distribution
011.3054 In distribution
011.2026 In distribution
011.0615 In distribution
011.2038 In distribution
011.0866 In distribution
011.7122 In distribution
011.0865 In distribution
011.1020 In distribution
011.2040 In distribution
011.8111 In distribution
011.0811 In distribution
011.0616 In distribution
011.1022 In distribution
011.0261 In distribution
011.4075 In distribution
011.4090 In distribution
011.2034 In distribution
011.0467 In distribution
011.4078 In distribution
011.4093 In distribution
011.0420 In distribution
011.0662 In distribution
011.1024 In distribution
011.3045 In distribution
011.3069 In distribution
011.0488 In distribution
011.0484 In distribution
011.0284 In distribution
011.0213 In distribution
011.0836 In distribution
011.3063 In distribution
011.1018 In distribution
011.0632 In distribution
011.0468 In distribution
011.0262 In distribution
011.0614 In distribution
011.0461 In distribution
011.0634 In distribution
011.0410 In distribution
011.3060 In distribution
011.7140 In distribution
011.3039 In distribution
011.0813 In distribution
011.0415 In distribution
011.8110 In distribution
011.4081 In distribution
011.0816 In distribution
011.5101 In distribution
011.0819 In distribution
011.0432 In distribution
011.0266 In distribution
011.0665 In distribution
011.0464 In distribution
011.4060 In distribution
011.3066 In distribution
011.0619 In distribution
011.0863 In distribution
011.7111 In distribution
011.4087 In distribution
011.7124 In distribution
011.0263 In distribution
011.0664 In distribution
011.2044 In distribution
011.0814 In distribution
011.0214 In distribution
011.0867 In distribution
011.0470 In distribution
011.5095 In distribution
011.0219 In distribution
011.0212 In distribution
011.0218 In distribution
011.1062 In distribution
011.0612 In distribution
011.3048 In distribution
011.7125 In distribution
011.7145 In distribution
011.1026 In distribution
011.0414 In distribution
011.0469 In distribution
011.0666 In distribution
011.0419 In distribution
011.8112 In distribution
011.0264 In distribution
011.7126 In distribution
011.1014 In distribution
011.5092 In distribution
011.2024 In distribution
011.0861 In distribution
011.5080 In distribution
011.0267 In distribution
011.2124 In distribution
011.0810 In distribution
011.0265 In distribution
011.1028 In distribution
011.8720 In distribution
011.3139 In distribution
011.0869 In distribution
011.0270 In distribution
011.0817 In distribution
011.0220 In distribution
011.0490 In distribution
011.0418 In distribution
011.0460 In distribution
011.0636 In distribution
011.0611 In distribution
011.7141 In distribution
011.0820 In distribution
011.0668 In distribution
011.0613 In distribution
011.0434 In distribution
011.4084 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K231715 2024-01-26
K220334 2022-11-09

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer