Degas Anterior Cervical Plate System

DEGAS Anterior Cervical Plate, 4 Level, HH102mm

Registry build 21.09.26
14manufacturers in China registered for this device type
94catalogue 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 Degas 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
Record published 2016-02-26
Record revised 2025-11-20 (version 6)

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 Degas Anterior Cervical Plate System
Catalogue number Size Status
010.1112 In distribution
010.1214 In distribution
010.1516 In distribution
010.0242 In distribution
010.1610 In distribution
010.0372 In distribution
010.0357 In distribution
010.0506 In distribution
010.0486 In distribution
010.0478 In distribution
010.0369 In distribution
010.0122 In distribution
010.1116 In distribution
010.1816 In distribution
010.1118 In distribution
010.1316 In distribution
010.0132 In distribution
010.1110 In distribution
010.1712 In distribution
010.0482 In distribution
010.1512 In distribution
010.0236 In distribution
010.0240 In distribution
010.0375 In distribution
010.1614 In distribution
010.1318 In distribution
010.0360 In distribution
010.1618 In distribution
010.0244 In distribution
010.1612 In distribution
010.1820 In distribution
010.1720 In distribution
010.1520 In distribution
010.0351 In distribution
010.1120 In distribution
010.0248 In distribution
010.0494 In distribution
010.1514 In distribution
010.1716 In distribution
010.7022 In distribution
010.1510 In distribution
010.0366 In distribution
010.1320 In distribution
010.0252 In distribution
010.1714 In distribution
010.1418 In distribution
010.1220 In distribution
010.1812 In distribution
010.0128 In distribution
010.1216 In distribution
010.1314 In distribution
010.0498 In distribution
010.1620 In distribution
010.7032 In distribution
010.0490 In distribution
010.0246 In distribution
010.1420 In distribution
010.0124 In distribution
010.1414 In distribution
010.1616 In distribution
010.1210 In distribution
010.7002 In distribution
010.0502 In distribution
010.7031 In distribution
010.1810 In distribution
010.0354 In distribution
010.0134 In distribution
010.0238 In distribution
010.0250 In distribution
010.1410 In distribution
010.1814 In distribution
010.0510 In distribution
010.0378 In distribution
010.1310 In distribution
010.0126 In distribution
010.0130 In distribution
010.1518 In distribution
010.1212 In distribution
010.0120 In distribution
010.0466 In distribution
010.0470 In distribution
010.0348 In distribution
010.0363 In distribution
010.1412 In distribution
010.0234 In distribution
010.1710 In distribution
010.1718 In distribution
010.0254 In distribution
010.1416 In distribution
010.1312 In distribution
010.1818 In distribution
010.1114 In distribution
010.0474 In distribution
010.1218 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