Zenius Spinal System
Polyaxial Reduction Pedicle Screw, Ø8.5mm X 55.0mm , Ø5.5 Rod
14manufacturers in China registered for this device type
405catalogue 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.
| 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
| Listed by | Medyssey Co., Ltd., South Korea |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer |
| Record published | 2018-07-04 |
| Record revised | 2024-10-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-09-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPO5595 | In distribution | |
| SMO6065 | In distribution | |
| SPO6595 | In distribution | |
| SRM7575 | In distribution | |
| SPO8590 | In distribution | |
| SRM9565 | In distribution | |
| SRP7595 | In distribution | |
| SRP6565 | In distribution | |
| SMO6590 | In distribution | |
| SPO7565 | In distribution | |
| SPO4550 | In distribution | |
| SPO5585 | In distribution | |
| SPO9050 | In distribution | |
| SRP5565 | In distribution | |
| SRM5070 | In distribution | |
| SPO8530 | In distribution | |
| SRP6585 | In distribution | |
| SPO9080 | In distribution | |
| SRM9045 | In distribution | |
| SRP6595 | In distribution | |
| SRP5575 | In distribution | |
| CLZ036 | In distribution | |
| SRM5080 | In distribution | |
| SMO9050 | In distribution | |
| SRM5585 | In distribution | |
| SPO7575 | In distribution | |
| SRP8555 | In distribution | |
| SRP8540 | In distribution | |
| SPO5555 | In distribution | |
| SMO5585 | In distribution | |
| SMO6095 | In distribution | |
| SMO7075 | In distribution | |
| SMO9570 | In distribution | |
| SRM8080 | In distribution | |
| CLZ056 | In distribution | |
| SPO10040 | In distribution | |
| CLZ166 | In distribution | |
| SRM6565 | In distribution | |
| SPO6575 | In distribution | |
| SMO9550 | In distribution | |
| SPO4055 | In distribution | |
| SMO9580 | In distribution | |
| SRM9555 | In distribution | |
| SRM9545 | In distribution | |
| SRM8595 | In distribution | |
| SPO7595 | In distribution | |
| SMO8085 | In distribution | |
| SPO6090 | In distribution | |
| CLZ066 | In distribution | |
| SPO8055 | In distribution | |
| SRP8095 | In distribution | |
| SPO8580 | In distribution | |
| SRP7575 | In distribution | |
| SPO9090 | In distribution | |
| SRP7080 | In distribution | |
| SPO10070 | In distribution | |
| SRP8035 | In distribution | |
| SRM4560 | In distribution | |
| SMO9540 | In distribution | |
| SMO7085 | In distribution | |
| SPO4560 | In distribution | |
| SRM9055 | In distribution | |
| SRP6080 | In distribution | |
| CLZ136 | In distribution | |
| SMO4560 | In distribution | |
| SRP5070 | In distribution | |
| CLZ046 | In distribution | |
| SPO8065 | In distribution | |
| SRM6090 | In distribution | |
| SRP5555 | In distribution | |
| SRM6070 | In distribution | |
| SPO6565 | In distribution | |
| SPO8095 | In distribution | |
| SRM9575 | In distribution | |
| SPO9570 | In distribution | |
| SPO9550 | In distribution | |
| SRP4550 | In distribution | |
| SRM7595 | In distribution | |
| SRP8075 | In distribution | |
| SRP7070 | In distribution | |
| SMO6570 | In distribution | |
| SRP5060 | In distribution | |
| SRM5090 | In distribution | |
| SRP5595 | In distribution | |
| SRM9065 | In distribution | |
| SRP7565 | In distribution | |
| SPO8045 | In distribution | |
| SPO9560 | In distribution | |
| SPO9580 | In distribution | |
| SRP6090 | In distribution | |
| SMO6075 | In distribution | |
| SRP6575 | In distribution | |
| SMO5595 | In distribution | |
| SPO9030 | In distribution | |
| SPO9040 | In distribution | |
| CLZ151 | In distribution | |
| SMO9080 | In distribution | |
| SMO9070 | In distribution | |
| SMO5080 | In distribution | |
| SMO8590 | In distribution | |
| CLZ161 | In distribution | |
| SRM6595 | In distribution | |
| SPO6070 | In distribution | |
| SMO7570 | In distribution | |
| SRM5575 | In distribution | |
| SPO9070 | In distribution | |
| SMO4550 | In distribution | |
| SMO6580 | In distribution | |
| SPO7080 | In distribution | |
| SRP7090 | In distribution | |
| SMO8065 | In distribution | |
| SRM4550 | In distribution | |
| SRP8045 | In distribution | |
| SMO5090 | In distribution | |
| SRM6585 | In distribution | |
| SRM8565 | In distribution | |
| SRM9535 | In distribution | |
| SMO5060 | In distribution | |
| SMO8075 | In distribution | |
| SRM9585 | In distribution | |
| SMO5575 | In distribution | |
| SRM9035 | In distribution | |
| SPO10060 | In distribution | |
| SPO5575 | In distribution | |
| SMO4055 | In distribution | |
| SMO7590 | In distribution | |
| SRM8070 | In distribution | |
| SMO9090 | In distribution | |
| SRM5060 | In distribution | |
| SMO5555 | In distribution | |
| SRM9085 | In distribution | |
| SPO8540 | In distribution | |
| SRP5585 | In distribution | |
| SRM9595 | In distribution | |
| SMO9060 | In distribution | |
| SRM8585 | In distribution | |
| SPO10050 | In distribution | |
| SRM4055 | In distribution | |
| SRM6080 | In distribution | |
| SRM5595 | In distribution | |
| SRM7090 | In distribution | |
| SPO6585 | In distribution | |
| SRM8575 | In distribution | |
| SPO5090 | In distribution | |
| SRP4560 | In distribution | |
| SRM9075 | In distribution | |
| SRM7585 | In distribution | |
| SPO10080 | In distribution | |
| SRM5565 | In distribution | |
| SPO9590 | In distribution | |
| SPO8525 | In distribution | |
| SRP8550 | In distribution | |
| SRP6070 | In distribution | |
| SPO8035 | In distribution | |
| SPO10030 | In distribution | |
| SPO8570 | In distribution | |
| SRM7070 | In distribution | |
| SRP5090 | In distribution | |
| SMO7065 | In distribution | |
| SMO5070 | In distribution | |
| SRP8055 | In distribution | |
| SRM7080 | In distribution | |
| SMO6085 | In distribution | |
| SPO9530 | In distribution | |
| SMO8570 | In distribution | |
| SRP8085 | In distribution | |
| SRM9095 | In distribution | |
| SPO9540 | In distribution | |
| SRM6575 | In distribution | |
| CLZ146 | In distribution | |
| SRM8090 | In distribution | |
| SRP4055 | In distribution | |
| SPO5070 | In distribution | |
| SPO9060 | In distribution | |
| SRP5080 | In distribution | |
| SMO7580 | In distribution | |
| SPO7585 | In distribution | |
| SPO7090 | In distribution | |
| SPO8550 | In distribution | |
| SRP8065 | In distribution | |
| SMO9530 | In distribution | |
| SRM5555 | In distribution | |
| SMO8095 | In distribution | |
| SPO5060 | In distribution | |
| SPO5565 | In distribution | |
| SMO7095 | In distribution | |
| SPO8560 | In distribution | |
| SMO9030 | In distribution | |
| SPO6080 | In distribution | |
| SPO8085 | In distribution | |
| SMO9590 | In distribution | |
| SPO8075 | In distribution | |
| SMO9560 | In distribution | |
| SMO5565 | In distribution | |
| SMO8580 | In distribution | |
| SPO5080 | In distribution | |
| SRP7585 | In distribution | |
| SPO10090 | In distribution | |
| SRM7565 | In distribution | |
| SPO7070 | In distribution | |
| SMO9040 | In distribution | |
| ZRP5075 | Withdrawn | |
| ZPO8080 | Withdrawn | |
| ZRM5560 | Withdrawn | |
| ZRP5055 | Withdrawn | |
| ZRP6095 | Withdrawn | |
| SPO8020 | Withdrawn | |
| ZPO8070 | Withdrawn | |
| ZPO7065 | Withdrawn | |
| ZMO7585 | Withdrawn | |
| ZPO4060 | Withdrawn | |
| ZRP7075 | Withdrawn | |
| ZRM9080 | Withdrawn | |
| ZRP7085 | Withdrawn | |
| ZRM9050 | Withdrawn | |
| SMO9020 | Withdrawn | |
| ZMO7565 | Withdrawn | |
| ZRM7095 | Withdrawn | |
| ZPO6580 | Withdrawn | |
| ZPO9565 | Withdrawn | |
| ZRM8580 | Withdrawn | |
| ZRM8065 | Withdrawn | |
| ZRM8095 | Withdrawn | |
| ZMO5590 | Withdrawn | |
| ZPO5075 | Withdrawn | |
| ZPO9095 | Withdrawn | |
| ZMO6090 | Withdrawn | |
| ZMO9055 | Withdrawn | |
| ZMO6575 | Withdrawn | |
| ZMO9075 | Withdrawn | |
| ZMO6070 | Withdrawn | |
| ZRM6085 | Withdrawn | |
| ZRM7075 | Withdrawn | |
| ZRM7590 | Withdrawn | |
| ZPO9075 | Withdrawn | |
| ZRM9030 | Withdrawn | |
| ZMO9545 | Withdrawn | |
| ZRM6590 | Withdrawn | |
| ZRP8070 | Withdrawn | |
| ZMO7080 | Withdrawn | |
| ZPO6590 | Withdrawn | |
| ZPO9035 | Withdrawn | |
| ZPO10085 | Withdrawn | |
| ZRM9540 | Withdrawn | |
| ZPO5065 | Withdrawn | |
| ZRM9580 | Withdrawn | |
| ZMO5570 | Withdrawn | |
| ZPO9045 | Withdrawn | |
| ZMO4555 | Withdrawn | |
| ZRM7085 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same 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.