Xia® 3 System – Serrato®

4826195100V

Registry build 21.09.26
14manufacturers in China registered for this device type
37catalogue 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.

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 Xia® 3 System – Serrato®
Listed by VB Spine LLC
FDA product code KWQ
Device type Appliance, Fixation, Spinal Intervertebral Body
Device class Class 2
Regulation 21 CFR 888.3060
Record published 2026-07-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Prescription Prescription only
Label carries lot or batch number
Sizes Outer diameter 4 to 10 mm; length 10 to 100 mm

Catalogue Numbers

Catalogue numbers for Xia® 3 System – Serrato®
Catalogue number Size Status
489617545V Outer Diameter 7.5 mm In distribution
482616060V Outer Diameter 6 mm In distribution
482616530V Length 30 mm In distribution
482616565V Length 65 mm In distribution
482614020V Length 20 mm In distribution
482614530V Length 30 mm In distribution
482619540V Outer Diameter 9.5 mm In distribution
482618550V Outer Diameter 8.5 mm In distribution
482627555V Length 55 mm In distribution
482678580V Length 80 mm In distribution
482615545V Outer Diameter 5.5 mm In distribution
482617035V Outer Diameter 7 mm In distribution
4826195100V Length 100 mm In distribution
482625555V Outer Diameter 5.5 mm In distribution
482617530V Length 30 mm In distribution
489615560V Length 60 mm In distribution
482627550V Length 50 mm In distribution
482615035V Length 35 mm In distribution
4826115100V Length 100 mm In distribution
482619555V Outer Diameter 9.5 mm In distribution
4826115110V Length 10 mm In distribution
482625560V Outer Diameter 5.5 mm In distribution
489616540V Outer Diameter 6.5 mm In distribution
482618590V Outer Diameter 8.5 mm In distribution
482626535V Outer Diameter 6.5 mm In distribution
482617570V Length 70 mm In distribution
482678570V Outer Diameter 8.5 mm In distribution
482616040V Outer Diameter 6 mm In distribution
489615550V Length 50 mm In distribution
482617555V Length 55 mm In distribution
482611570V Length 70 mm In distribution
482627530V Outer Diameter 7.5 mm In distribution
482614535V Outer Diameter 4.5 mm In distribution
489615545V Length 45 mm In distribution
482625550V Length 50 mm In distribution
4826185100V Outer Diameter 8.5 mm In distribution
482611580V Outer Diameter 10 mm 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

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