XIA 3
Parallel Revision Connector Open-Closed
13manufacturers in China registered for this device type
102catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2014-12-08 |
| Record revised | 2024-09-11 (version 10) |
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 |
| Sizes | Length 12 to 480 mm |
| Distribution end date | 2024-06-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 482306580 | Length 80.0 mm | In distribution |
| 482317560 | Diameter: 7.5 Millimeter | In distribution |
| 482315555 | Diameter: 5.5 Millimeter | In distribution |
| 482378535 | Length 35.0 mm | In distribution |
| 48230217 | In distribution | |
| 48230144 | In distribution | |
| 48230211 | In distribution | |
| 482319540 | Diameter: 9.5 Millimeter | In distribution |
| 48235008 | Length 22.0 mm | In distribution |
| 482379530 | Diameter: 9.5 Millimeter | In distribution |
| 482306025 | Length 25.0 mm | In distribution |
| 482306535 | Diameter: 6.5 Millimeter | In distribution |
| 482335030 | Length 30.0 mm | In distribution |
| 482309560 | Length 60.0 mm | In distribution |
| 4823716555 | Diameter: 6.5 Millimeter | In distribution |
| 482376540 | Length 40.0 mm | In distribution |
| 48230204 | In distribution | |
| 482317040 | Diameter: 7.0 Millimeter | In distribution |
| 482316035 | Diameter: 6.0 Millimeter | In distribution |
| 482384530 | Length 30.0 mm | In distribution |
| 48235007 | Length 12.0 mm | In distribution |
| 482377580 | Length 80.0 mm | In distribution |
| 482314525 | Length 25.0 mm | In distribution |
| 48230232 | In distribution | |
| 482315025 | Length 25.0 mm | In distribution |
| 482316040 | Length 40.0 mm | In distribution |
| 48235050 | Diameter: 6.0 Millimeter | In distribution |
| 482308555 | Length 55.0 mm | In distribution |
| 482308535 | Diameter: 8.5 Millimeter | In distribution |
| 482318560 | Length 60.0 mm | In distribution |
| 482336050 | Length 50.0 mm | In distribution |
| 482307565 | Diameter: 7.5 Millimeter | In distribution |
| 48230260R | In distribution | |
| 4823715045 | Length 45.0 mm | In distribution |
| 482337045 | Diameter: 7.0 Millimeter | In distribution |
| 482306055 | Diameter: 6.0 Millimeter | In distribution |
| 482304540 | Diameter: 4.5 Millimeter | In distribution |
| 482366560 | Length 60.0 mm | In distribution |
| 482305025 | Length 25.0 mm | In distribution |
| 48230139 | In distribution | |
| 48230203 | In distribution | |
| 482366555 | Length 55.0 mm | In distribution |
| 482308580 | Length 80.0 mm | In distribution |
| 482366050 | Diameter: 6.0 Millimeter | In distribution |
| 48230233 | In distribution | |
| 482311540 | Diameter: 10.5 Millimeter | In distribution |
| 482387565 | Length 65.0 mm | In distribution |
| 482306045 | Length 45.0 mm | In distribution |
| 482316065 | Length 65.0 mm | In distribution |
| 482307530 | Diameter: 7.5 Millimeter | In distribution |
| 48238550 | Length 50.0 mm | In distribution |
| 482317080 | Length 80.0 mm | In distribution |
| 48233480 | Diameter: 6.0 Millimeter | In distribution |
| 482318550 | Length 50.0 mm | In distribution |
| 482386540 | Diameter: 6.5 Millimeter | In distribution |
| 482377590 | Diameter: 7.5 Millimeter | In distribution |
| 482305020 | Diameter: 5.0 Millimeter | In distribution |
| 482311545 | Diameter: 10.5 Millimeter | In distribution |
| 482314540 | Diameter: 4.5 Millimeter | In distribution |
| 482308545 | Length 45.0 mm | In distribution |
| 482364520 | Length 20.0 mm | In distribution |
| 482379540 | Diameter: 9.5 Millimeter | In distribution |
| 482319555 | Length 55.0 mm | In distribution |
| 48230202 | In distribution | |
| 482307580 | Diameter: 7.5 Millimeter | In distribution |
| 4823715535 | Diameter: 5.5 Millimeter | In distribution |
| 482386580 | Length 80.0 mm | In distribution |
| 4823714045 | Length 45.0 mm | In distribution |
| 482318565 | Length 65.0 mm | In distribution |
| 48236550 | Length 50.0 mm | In distribution |
| 48233625 | Diameter: 6.5 Millimeter | In distribution |
| 482306560 | Diameter: 6.5 Millimeter | In distribution |
| 482316070 | Length 70.0 mm | In distribution |
| 482365035 | Diameter: 5.0 Millimeter | In distribution |
| 482388500 | Diameter: 8.5 Millimeter | In distribution |
| 482309570 | Diameter: 9.5 Millimeter | In distribution |
| 48237550 | Diameter: 7.5 Millimeter | In distribution |
| 48233445 | Diameter: 4.5 Millimeter | In distribution |
| 482366525 | Length 25.0 mm | In distribution |
| 482307030 | Diameter: 7.0 Millimeter | In distribution |
| 482319570 | Diameter: 9.5 Millimeter | In distribution |
| 4823715555 | Length 55.0 mm | In distribution |
| 48230220 | In distribution | |
| 48236035 | In distribution | |
| 482309500 | Length 100.0 mm | In distribution |
| 482365025 | Length 25.0 mm | In distribution |
| 4823714025 | Diameter: 4.0 Millimeter | In distribution |
| 48235110 | Length 110.0 mm | In distribution |
| 482308500 | Length 100.0 mm | In distribution |
| 482388570 | Diameter: 8.5 Millimeter | In distribution |
| 482398560 | Diameter: 8.5 Millimeter | Withdrawn |
| 482328590 | Diameter: 8.5 Millimeter | Withdrawn |
| 482329530 | Length 30.0 mm | Withdrawn |
| 482329500 | Length 100.0 mm | Withdrawn |
| 482399500 | Length 100.0 mm | Withdrawn |
| 482326545 | Diameter: 6.5 Millimeter | Withdrawn |
| 482326565 | Diameter: 6.5 Millimeter | Withdrawn |
| 482397560 | Diameter: 7.5 Millimeter | Withdrawn |
| 482398580 | Length 80.0 mm | Withdrawn |
| 482396560 | Diameter: 6.5 Millimeter | Withdrawn |
| 482328580 | Diameter: 8.5 Millimeter | Withdrawn |
| 482329580 | Length 80.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
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.