Prase-C Anterior Cervical Plate System

347 catalogue numbers from C122-3710, listed by Gbs Commonwealth Co., Ltd., South Korea, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.

Registry build 21.09.26
11manufacturers in China registered for this device type
347catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWP
Manufacturer City Province Registered as Device types
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
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
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for Prase-C Anterior Cervical Plate System
Listed by Gbs Commonwealth Co., Ltd., South Korea
FDA product code KWP
Device type Appliance, Fixation, Spinal Interlaminal
Device class Class 2
Regulation 21 CFR 888.3050
510(k) K211205
Record published 2021-09-30
Record revised 2026-06-23 (version 4)

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
Distribution end date 2026-06-22

Catalogue Numbers

Catalogue numbers for Prase-C Anterior Cervical Plate System
Catalogue number Size Status
C122-3710 In distribution
C128-3716 In distribution
C121-4216 In distribution
C127-4211 In distribution
C124-4224 In distribution
C122-4217 In distribution
C123-4212 In distribution
C124-4217 In distribution
C126-4218 In distribution
C128-4225 In distribution
C126-3713 In distribution
C111-1730 In distribution
C125-3726 In distribution
C125-4213 In distribution
C123-3720 In distribution
C125-4219 In distribution
C123-3715 In distribution
C125-3710 In distribution
C126-4221 In distribution
C126-3715 In distribution
C127-3715 In distribution
C122-4219 In distribution
C122-3726 In distribution
C114-1793 In distribution
C125-4224 In distribution
C122-4215 In distribution
C127-4221 In distribution
C116-1720 In distribution
C125-3720 In distribution
C117-1722 In distribution
C128-4226 In distribution
C128-3713 In distribution
C117-1721 In distribution
C124-4225 In distribution
C123-4213 In distribution
C121-3726 In distribution
C124-4219 In distribution
C127-4218 In distribution
C127-4212 In distribution
C124-4226 In distribution
C128-3726 In distribution
C125-4222 In distribution
C121-3722 In distribution
C122-3722 In distribution
C127-4214 In distribution
C128-3719 In distribution
C124-4211 In distribution
C123-3724 In distribution
C124-3717 In distribution
C123-4221 In distribution
C126-3719 In distribution
C126-3718 In distribution
C122-4211 In distribution
C124-4220 In distribution
C121-4225 In distribution
C111-1717 In distribution
C125-4225 In distribution
C121-3720 In distribution
C124-4223 In distribution
C112-1746 In distribution
C127-3723 In distribution
C126-4226 In distribution
C125-4217 In distribution
C122-3714 In distribution
C124-3712 In distribution
C127-3721 In distribution
C128-4220 In distribution
C125-4221 In distribution
C125-4220 In distribution
C114-1761 In distribution
C126-4212 In distribution
C128-4221 In distribution
C116-1718 In distribution
C124-3726 In distribution
C121-4222 In distribution
C126-4215 In distribution
C124-3714 In distribution
C121-4211 In distribution
C125-4218 In distribution
C124-4213 In distribution
C128-4219 In distribution
C125-3725 In distribution
C112-1754 In distribution
C127-3724 In distribution
C116-1717 In distribution
C126-4223 In distribution
C124-3713 In distribution
C122-4213 In distribution
C128-4223 In distribution
C121-3711 In distribution
C123-4220 In distribution
C112-1752 In distribution
C125-4211 In distribution
C125-3718 In distribution
C126-4213 In distribution
C127-3719 In distribution
C122-3718 In distribution
C115-17100 In distribution
C121-4221 In distribution
C128-3723 In distribution
C123-3712 In distribution
C122-3721 In distribution
C128-3721 In distribution
C122-4222 In distribution
C113-1748 In distribution
C127-4225 In distribution
C126-3716 In distribution
C115-17110 In distribution
C127-4213 In distribution
C124-4210 In distribution
C125-3716 In distribution
C122-4212 In distribution
C123-3726 In distribution
C127-3725 In distribution
C112-1750 In distribution
C125-4226 In distribution
C123-3722 In distribution
C124-3724 In distribution
C126-3723 In distribution
C124-3721 In distribution
C126-3722 In distribution
C125-3714 In distribution
C127-3716 In distribution
C111-1732 In distribution
C126-4225 In distribution
C124-3710 In distribution
C113-1760 In distribution
C122-3711 In distribution
C122-3712 In distribution
C127-3713 In distribution
C124-3716 In distribution
C116-1722 In distribution
C123-3721 In distribution
C114-1781 In distribution
C123-3718 In distribution
C125-4210 In distribution
C111-1723 In distribution
C128-4214 In distribution
C111-1733 In distribution
C111-1722 In distribution
C126-4224 In distribution
C112-1736 In distribution
C127-4219 In distribution
C128-3712 In distribution
C128-4215 In distribution
C126-3721 In distribution
C121-3713 In distribution
C124-4214 In distribution
C121-3718 In distribution
C123-3714 In distribution
C123-3711 In distribution
C113-1766 In distribution
C128-3720 In distribution
C121-3721 In distribution
C123-4210 In distribution
C127-4222 In distribution
C112-1738 In distribution
C128-3711 In distribution
C117-1724 In distribution
C111-1727 In distribution
C121-3717 In distribution
C127-4217 In distribution
C125-3713 In distribution
C121-4217 In distribution
C125-3722 In distribution
C123-3723 In distribution
C124-3720 In distribution
C128-4213 In distribution
C122-3720 In distribution
C112-1744 In distribution
C121-3725 In distribution
C114-17101 In distribution
C122-3716 In distribution
C115-1795 In distribution
C126-4219 In distribution
C128-3724 In distribution
C123-4225 In distribution
C111-1731 In distribution
C125-3719 In distribution
C112-1742 In distribution
C127-4220 In distribution
C127-3714 In distribution
C124-3719 In distribution
C113-1772 In distribution
C111-1729 In distribution
C123-3713 In distribution
C127-3718 In distribution
C123-4217 In distribution
C121-4226 In distribution
C111-1719 In distribution
C124-3711 In distribution
C127-3712 In distribution
C127-3726 In distribution
C123-4226 In distribution
C121-3710 In distribution
C124-4216 In distribution
C116-1721 In distribution
C114-1785 In distribution
C122-4223 In distribution
C121-3719 In distribution
C123-3716 In distribution
C127-3711 In distribution
C121-4215 In distribution
C126-3724 In distribution
C122-3723 In distribution
C115-17105 In distribution
C128-4210 In distribution
C111-1728 In distribution
C128-3710 In distribution
C121-3714 In distribution
C124-3722 In distribution
C122-3725 In distribution
C124-3715 In distribution
C127-3722 In distribution
C123-3725 In distribution
C124-4221 In distribution
C113-1757 In distribution
C121-4220 In distribution
C121-4213 In distribution
C126-3726 In distribution
C123-4215 In distribution
C123-4223 In distribution
C122-3715 In distribution
C111-1736 In distribution
C122-4221 In distribution
C128-4217 In distribution
C111-1725 In distribution
C124-4212 In distribution
C126-4210 In distribution
C125-4216 In distribution
C123-4214 In distribution
C127-3710 In distribution
C114-1773 In distribution
C123-4224 In distribution
C121-3723 In distribution
C128-3722 In distribution
C116-1725 In distribution
C127-4215 In distribution
C128-3714 In distribution
C122-3719 In distribution
C126-4216 In distribution
C125-3712 In distribution
C111-1734 In distribution
C126-3717 In distribution
C123-4219 In distribution
C122-4218 In distribution
C111-1724 In distribution
C111-1726 In distribution
C126-3712 In distribution
C126-4222 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Invictus Alphatec Spine, Inc. 5,422
ReLine Nuvasive, Inc. 4,439
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 3,188
Creo Globus Medical, Inc. 1,992
Apex Spine System Spinecraft LLC 1,319
LnK Spinal Fixation System L&K Biomed Co., Ltd. 1,271
Perla ® TL Spineart SA 1,035
Astra Spine System Spinecraft LLC 1,003
LineSider Highridge Medical, LLC 948
Apex-DL Spine System Spinecraft LLC 909
Revere Globus Medical, Inc. 875
AccelFix Spinal Fixation System L&K Biomed Co., Ltd. 841

Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal

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