ES2 Spinal System
46 catalogue numbers from 482805065, listed by Stryker GmbH, Switzerland, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
46catalogue 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 | 2015-09-14 |
| Record revised | 2024-09-11 (version 8) |
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 20 to 600 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 482805065 | Diameter: 6.0 Millimeter | In distribution |
| 482804430 | Diameter: 4.5 Millimeter | In distribution |
| 482805130 | Length 130.0 mm | In distribution |
| 482802755 | Diameter: 7.5 Millimeter | In distribution |
| 482802555 | Length 55.0 mm | In distribution |
| 482807180 | Diameter: 5.5 Millimeter | In distribution |
| 482808030 | Diameter: 5.5 Millimeter | In distribution |
| 482807055 | Length 55.0 mm | In distribution |
| 482805170 | Length 170.0 mm | In distribution |
| 482802640 | Length 40.0 mm | In distribution |
| 482805045 | Diameter: 6.0 Millimeter | In distribution |
| 482805030 | Diameter: 6.0 Millimeter | In distribution |
| 482808120 | Diameter: 5.5 Millimeter | In distribution |
| 482805075 | Length 75.0 mm | In distribution |
| 482804830 | Diameter: 8.5 Millimeter | In distribution |
| 482805020 | Length 20.0 mm | In distribution |
| 482807600 | Diameter: 5.5 Millimeter | In distribution |
| 482802655 | Diameter: 6.5 Millimeter | In distribution |
| 482804780 | Length 80.0 mm | In distribution |
| 482805180 | Diameter: 6.0 Millimeter | In distribution |
| 482804855 | Length 55.0 mm | In distribution |
| 482808600 | Diameter: 5.5 Millimeter | In distribution |
| 482804655 | Length 55.0 mm | In distribution |
| 482805080 | Diameter: 6.0 Millimeter | In distribution |
| 482807150 | Diameter: 5.5 Millimeter | In distribution |
| 482806035 | Length 35.0 mm | In distribution |
| 482802850 | Diameter: 8.5 Millimeter | In distribution |
| 482804555 | Diameter: 5.5 Millimeter | In distribution |
| 482804435 | Length 35.0 mm | In distribution |
| 482808170 | Length 170.0 mm | In distribution |
| 482804445 | Diameter: 4.5 Millimeter | In distribution |
| 482804880 | Length 80.0 mm | In distribution |
| 482802750 | Diameter: 7.5 Millimeter | In distribution |
| 482808080 | Diameter: 5.5 Millimeter | In distribution |
| 482807130 | Diameter: 5.5 Millimeter | In distribution |
| 482806050 | Length 50.0 mm | In distribution |
| 482807140 | Length 140.0 mm | In distribution |
| 482804645 | Diameter: 6.5 Millimeter | In distribution |
| 482807480 | Length 480.0 mm | In distribution |
| 482804540 | Diameter: 5.5 Millimeter | In distribution |
| 482805100 | Diameter: 6.0 Millimeter | In distribution |
| 482807070 | Length 70.0 mm | In distribution |
| 482806080 | Length 80.0 mm | In distribution |
| 482808150 | Diameter: 5.5 Millimeter | In distribution |
| 482804530 | Diameter: 5.5 Millimeter | In distribution |
| 482802830 | Length 30.0 mm | In distribution |
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.