Xia® 3 System – Serrato®
4826115130V
15manufacturers in China registered for this device type
60catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2026-07-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 10 to 100 mm; outer diameter 4 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4826115130V | Length 30 mm | In distribution |
| 482611560V | Outer Diameter 10 mm | In distribution |
| 482616050V | Length 50 mm | In distribution |
| 482619565V | Outer Diameter 9.5 mm | In distribution |
| 482616590V | Length 90 mm | In distribution |
| 482616555V | Length 55 mm | In distribution |
| 482616535V | Length 35 mm | In distribution |
| 482615550V | Outer Diameter 5.5 mm | In distribution |
| 4826185120V | Outer Diameter 8.5 mm | In distribution |
| 482617550V | Length 50 mm | In distribution |
| 482617030V | Outer Diameter 7 mm | In distribution |
| 489616535V | Length 35 mm | In distribution |
| 482617045V | Length 45 mm | In distribution |
| 482677580V | Outer Diameter 7.5 mm | In distribution |
| 489617560V | Outer Diameter 7.5 mm | In distribution |
| 482678590V | Outer Diameter 8.5 mm | In distribution |
| 482614520V | Outer Diameter 4.5 mm | In distribution |
| 482617545V | Length 45 mm | In distribution |
| 482677570V | Length 70 mm | In distribution |
| 482617050V | Outer Diameter 7 mm | In distribution |
| 482619545V | Outer Diameter 9.5 mm | In distribution |
| 482615535V | Outer Diameter 5.5 mm | In distribution |
| 482618535V | Outer Diameter 8.5 mm | In distribution |
| 482611540V | Outer Diameter 10 mm | In distribution |
| 482627560V | Outer Diameter 7.5 mm | In distribution |
| 482626540V | Outer Diameter 6.5 mm | In distribution |
| 482619550V | Outer Diameter 9.5 mm | In distribution |
| 482619590V | Outer Diameter 9.5 mm | In distribution |
| 482617535V | Length 35 mm | In distribution |
| 482615525V | Outer Diameter 5.5 mm | In distribution |
| 489617535V | Length 35 mm | In distribution |
| 482616545V | Outer Diameter 6.5 mm | In distribution |
| 482625530V | Outer Diameter 5.5 mm | In distribution |
| 482625540V | Outer Diameter 5.5 mm | In distribution |
| 482615555V | Outer Diameter 5.5 mm | In distribution |
| 482626550V | Length 50 mm | In distribution |
| 4826175100V | Outer Diameter 7.5 mm | In distribution |
| 482617055V | Outer Diameter 7 mm | In distribution |
| 482611555V | Outer Diameter 10 mm | In distribution |
| 489615530V | Outer Diameter 5.5 mm | In distribution |
| 489617540V | Outer Diameter 7.5 mm | In distribution |
| 4826195130V | Outer Diameter 9.5 mm | In distribution |
| 482614030V | Outer Diameter 4 mm | In distribution |
| 482614035V | Length 35 mm | In distribution |
| 482615030V | Length 30 mm | In distribution |
| 482616560V | Outer Diameter 6.5 mm | In distribution |
| 482617565V | Length 65 mm | In distribution |
| 482616035V | Length 35 mm | In distribution |
| 482617590V | Length 90 mm | In distribution |
| 4826195110V | Outer Diameter 9.5 mm | In distribution |
| 482617580V | Outer Diameter 7.5 mm | In distribution |
| 489617555V | Length 55 mm | In distribution |
| 482615560V | Outer Diameter 5.5 mm | In distribution |
| 482618560V | Length 60 mm | In distribution |
| 482618530V | Length 30 mm | In distribution |
| 489616545V | Length 45 mm | In distribution |
| 482615045V | Outer Diameter 5 mm | In distribution |
| 482626530V | Length 30 mm | In distribution |
| 482626545V | Length 45 mm | In distribution |
| 482614545V | Outer Diameter 4.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
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.