Xia 3 System – Serrato
Medial Biased-Angle Polyaxial Screw
15manufacturers in China registered for this device type
183catalogue numbers in this listing
10510(k) clearances naming this product code
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-02-07 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 20 to 130 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 482615555 | Diameter: 5.5 Millimeter | In distribution |
| 482616550 | Length 50.0 mm | In distribution |
| 482625545 | Length 45.0 mm | In distribution |
| 482615545 | Diameter: 5.5 Millimeter | In distribution |
| 482615540 | Diameter: 5.5 Millimeter | In distribution |
| 482616035 | Diameter: 6.0 Millimeter | In distribution |
| 482626535 | Length 35.0 mm | In distribution |
| 482611570 | Diameter: 10.5 Millimeter | In distribution |
| 4826115100 | Diameter: 10.5 Millimeter | In distribution |
| 482625535 | Length 35.0 mm | In distribution |
| 4826165120 | Length 120.0 mm | In distribution |
| 489615540 | Length 40.0 mm | In distribution |
| 482618550 | Diameter: 8.5 Millimeter | In distribution |
| 482614030 | Diameter: 4.0 Millimeter | In distribution |
| 482617550 | Length 50.0 mm | In distribution |
| 489617550 | Diameter: 7.5 Millimeter | In distribution |
| 4826185100 | Diameter: 8.5 Millimeter | In distribution |
| 4826160110 | Diameter: 6.0 Millimeter | In distribution |
| 482616045 | Diameter: 6.0 Millimeter | In distribution |
| 482619550 | Length 50.0 mm | In distribution |
| 482617570 | Diameter: 7.5 Millimeter | In distribution |
| 482614020 | Length 20.0 mm | In distribution |
| 482616580 | Length 80.0 mm | In distribution |
| 482617565 | Length 65.0 mm | In distribution |
| 482627550 | Diameter: 7.5 Millimeter | In distribution |
| 4826185120 | Length 120.0 mm | In distribution |
| 489617535 | Diameter: 7.5 Millimeter | In distribution |
| 482677590 | Diameter: 7.5 Millimeter | In distribution |
| 482619560 | Diameter: 9.5 Millimeter | In distribution |
| 482627540 | Length 40.0 mm | In distribution |
| 482617080 | Diameter: 7.0 Millimeter | In distribution |
| 482626545 | Diameter: 6.5 Millimeter | In distribution |
| 482625540 | Diameter: 5.5 Millimeter | In distribution |
| 4826175110 | Length 110.0 mm | In distribution |
| 482615050 | Length 50.0 mm | In distribution |
| 482616535 | Diameter: 6.5 Millimeter | In distribution |
| 482625555 | Diameter: 5.5 Millimeter | In distribution |
| 482616545 | Diameter: 6.5 Millimeter | In distribution |
| 482615535 | Length 35.0 mm | In distribution |
| 482614025 | Diameter: 4.0 Millimeter | In distribution |
| 482619580 | Diameter: 9.5 Millimeter | In distribution |
| 482618570 | Diameter: 8.5 Millimeter | In distribution |
| 482678590 | Diameter: 8.5 Millimeter | In distribution |
| 482617555 | Diameter: 7.5 Millimeter | In distribution |
| 482615530 | Length 30.0 mm | In distribution |
| 489615555 | Length 55.0 mm | In distribution |
| 482616055 | Length 55.0 mm | In distribution |
| 482677580 | Diameter: 7.5 Millimeter | In distribution |
| 4826195100 | Diameter: 9.5 Millimeter | In distribution |
| 489617545 | Length 45.0 mm | In distribution |
| 489615530 | Length 30.0 mm | In distribution |
| 482611560 | Length 60.0 mm | In distribution |
| 489616535 | Length 35.0 mm | In distribution |
| 482615045 | Diameter: 5.0 Millimeter | In distribution |
| 482677570 | Length 70.0 mm | In distribution |
| 489617555 | Diameter: 7.5 Millimeter | In distribution |
| 482625560 | Length 60.0 mm | In distribution |
| 482626530 | Length 30.0 mm | In distribution |
| 482611555 | Diameter: 10.5 Millimeter | In distribution |
| 489616530 | Diameter: 6.5 Millimeter | In distribution |
| 482611550 | Length 50.0 mm | In distribution |
| 4826195130 | Length 130.0 mm | In distribution |
| 482626540 | Length 40.0 mm | In distribution |
| 482617090 | Length 90.0 mm | In distribution |
| 482615025 | Length 25.0 mm | In distribution |
| 4826165100 | Length 100.0 mm | In distribution |
| 482616525 | Length 25.0 mm | In distribution |
| 482614545 | Diameter: 4.5 Millimeter | In distribution |
| 482618545 | Length 45.0 mm | In distribution |
| 482617545 | Length 45.0 mm | In distribution |
| 482614520 | Diameter: 4.5 Millimeter | In distribution |
| 482619540 | Diameter: 9.5 Millimeter | In distribution |
| 482626555 | Length 55.0 mm | In distribution |
| 482617070 | Length 70.0 mm | In distribution |
| 482618540 | Diameter: 8.5 Millimeter | In distribution |
| 482617535 | Length 35.0 mm | In distribution |
| 482619545 | Diameter: 9.5 Millimeter | In distribution |
| 482617530 | Length 30.0 mm | In distribution |
| 482616555 | Length 55.0 mm | In distribution |
| 4826175100 | Length 100.0 mm | In distribution |
| 482616540 | Diameter: 6.5 Millimeter | In distribution |
| 482617035 | Length 35.0 mm | In distribution |
| 489616555 | Length 55.0 mm | In distribution |
| 4826115120 | Diameter: 10.5 Millimeter | In distribution |
| 482614535 | Length 35.0 mm | In distribution |
| 482616530 | Diameter: 6.5 Millimeter | In distribution |
| 482611590 | Length 90.0 mm | In distribution |
| 4826165130 | Diameter: 6.5 Millimeter | In distribution |
| 482678570 | Diameter: 8.5 Millimeter | In distribution |
| 489616550 | Length 50.0 mm | In distribution |
| 482615040 | Diameter: 5.0 Millimeter | In distribution |
| 482678580 | Length 80.0 mm | In distribution |
| 482618580 | Length 80.0 mm | In distribution |
| 4826165110 | Diameter: 6.5 Millimeter | In distribution |
| 482615525 | Length 25.0 mm | In distribution |
| 4826175120 | Diameter: 7.5 Millimeter | In distribution |
| 482617025 | Length 25.0 mm | In distribution |
| 4826195110 | Length 110.0 mm | In distribution |
| 489615545 | Diameter: 5.5 Millimeter | In distribution |
| 482618525 | Length 25.0 mm | In distribution |
| 482611540 | Diameter: 10.5 Millimeter | In distribution |
| 4826195120 | Length 120.0 mm | In distribution |
| 482627560 | Diameter: 7.5 Millimeter | In distribution |
| 489615535 | Length 35.0 mm | In distribution |
| 482615560 | Length 60.0 mm | In distribution |
| 482619570 | Diameter: 9.5 Millimeter | In distribution |
| 482615035 | Diameter: 5.0 Millimeter | In distribution |
| 489614520 | Length 20.0 mm | In distribution |
| 489615560 | Length 60.0 mm | In distribution |
| 482617580 | Length 80.0 mm | In distribution |
| 482616560 | Diameter: 6.5 Millimeter | In distribution |
| 482625530 | Diameter: 5.5 Millimeter | In distribution |
| 482617055 | Diameter: 7.0 Millimeter | In distribution |
| 482616040 | Length 40.0 mm | In distribution |
| 482614530 | Length 30.0 mm | In distribution |
| 489615550 | Diameter: 5.5 Millimeter | In distribution |
| 482616025 | Diameter: 6.0 Millimeter | In distribution |
| 482616090 | Diameter: 6.0 Millimeter | In distribution |
| 482611545 | Diameter: 10.5 Millimeter | In distribution |
| 489614540 | Length 40.0 mm | In distribution |
| 482614040 | Diameter: 4.0 Millimeter | In distribution |
| 482615020 | Length 20.0 mm | In distribution |
| 482618565 | Diameter: 8.5 Millimeter | In distribution |
| 489616560 | Diameter: 6.5 Millimeter | In distribution |
| 482616050 | Length 50.0 mm | In distribution |
| 482617525 | Diameter: 7.5 Millimeter | In distribution |
| 482611580 | Diameter: 10.5 Millimeter | In distribution |
| 482616070 | Diameter: 6.0 Millimeter | In distribution |
| 4826170130 | Length 130.0 mm | In distribution |
| 482617045 | Length 45.0 mm | In distribution |
| 482616570 | Diameter: 6.5 Millimeter | In distribution |
| 482617040 | Length 40.0 mm | In distribution |
| 482627535 | Length 35.0 mm | In distribution |
| 4826115130 | Diameter: 10.5 Millimeter | In distribution |
| 482614525 | Diameter: 4.5 Millimeter | In distribution |
| 482626560 | Length 60.0 mm | In distribution |
| 482616030 | Length 30.0 mm | In distribution |
| 482616065 | Length 65.0 mm | In distribution |
| 489617530 | Length 30.0 mm | In distribution |
| 482614035 | Diameter: 4.0 Millimeter | In distribution |
| 482618555 | Length 55.0 mm | In distribution |
| 482618560 | Diameter: 8.5 Millimeter | In distribution |
| 482617050 | Diameter: 7.0 Millimeter | In distribution |
| 482618535 | Diameter: 8.5 Millimeter | In distribution |
| 4826185110 | Length 110.0 mm | In distribution |
| 482617590 | Length 90.0 mm | In distribution |
| 482627545 | Diameter: 7.5 Millimeter | In distribution |
| 489617540 | Diameter: 7.5 Millimeter | In distribution |
| 482619565 | Length 65.0 mm | In distribution |
| 482617540 | Length 40.0 mm | In distribution |
| 482611565 | Diameter: 10.5 Millimeter | In distribution |
| 4826170110 | Length 110.0 mm | In distribution |
| 4826160100 | Diameter: 6.0 Millimeter | In distribution |
| 482626550 | Diameter: 6.5 Millimeter | In distribution |
| 482619590 | Diameter: 9.5 Millimeter | In distribution |
| 482617030 | Length 30.0 mm | In distribution |
| 482617560 | Diameter: 7.5 Millimeter | In distribution |
| 482616080 | Length 80.0 mm | In distribution |
| 482617060 | Diameter: 7.0 Millimeter | In distribution |
| 489617560 | Diameter: 7.5 Millimeter | In distribution |
| 482616060 | Length 60.0 mm | In distribution |
| 482616565 | Length 65.0 mm | In distribution |
| 482618530 | Diameter: 8.5 Millimeter | In distribution |
| 4826175130 | Diameter: 7.5 Millimeter | In distribution |
| 4826115110 | Diameter: 10.5 Millimeter | In distribution |
| 4826170100 | Length 100.0 mm | In distribution |
| 4826185130 | Diameter: 8.5 Millimeter | In distribution |
| 489616540 | Length 40.0 mm | In distribution |
| 482617065 | Length 65.0 mm | In distribution |
| 482615030 | Diameter: 5.0 Millimeter | In distribution |
| 482614045 | Length 45.0 mm | In distribution |
| 482616590 | Diameter: 6.5 Millimeter | In distribution |
| 482614540 | Length 40.0 mm | In distribution |
| 4826160120 | Diameter: 6.0 Millimeter | In distribution |
| 482618590 | Length 90.0 mm | In distribution |
| 4826160130 | Length 130.0 mm | In distribution |
| 482625550 | Length 50.0 mm | In distribution |
| 482619555 | Length 55.0 mm | In distribution |
| 482627555 | Diameter: 7.5 Millimeter | In distribution |
| 4826170120 | Length 120.0 mm | In distribution |
| 489616545 | Length 45.0 mm | In distribution |
| 482615550 | Diameter: 5.5 Millimeter | In distribution |
| 482627530 | Diameter: 7.5 Millimeter | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172724 | 2017-10-10 |
| K170496 | 2017-05-16 |
| K152632 | 2015-12-02 |
| K142381 | 2014-10-21 |
| K121342 | 2012-06-22 |
| K120434 | 2012-03-08 |
| K111478 | 2011-08-04 |
| K103292 | 2011-03-04 |
| K073151 | 2007-12-06 |
| K070368 | 2007-05-04 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Spine | UDI-DI | 2019-06-18 | Class II | Labeling mix-ups | Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length. | 11 | 2020-05-22 |
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.