PSS System
Ø8.5 x 100mm Cannulated Reduction Pedicle Screw
13manufacturers in China registered for this device type
153catalogue 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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K092128 |
| Record published | 2019-05-02 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LAA5540 | In distribution | |
| SLC5560 | In distribution | |
| SLP8580 | In distribution | |
| SLPL6550 | In distribution | |
| SLPL6530 | In distribution | |
| 63-CS-8560 | In distribution | |
| SLP5535 | In distribution | |
| SLP6545 | In distribution | |
| SLP8560 | In distribution | |
| PSS6555 | In distribution | |
| SLPL4545 | In distribution | |
| 63-CR-8570 | In distribution | |
| SLP8570 | In distribution | |
| LAA5545 | In distribution | |
| 63-CR-7525 | In distribution | |
| SLP4530 | In distribution | |
| 63-CR-5560 | In distribution | |
| SLP7550 | In distribution | |
| SLPL5530 | In distribution | |
| 63-CR-5545 | In distribution | |
| SLPL6525 | In distribution | |
| SLPL5560 | In distribution | |
| 63-CS-6560 | In distribution | |
| 63-CR-6545 | In distribution | |
| SLC8580 | In distribution | |
| 63-CR-6540 | In distribution | |
| SLP7560 | In distribution | |
| SLP6555 | In distribution | |
| 63-CR-7545 | In distribution | |
| SLPL7530 | In distribution | |
| 110-5570 | In distribution | |
| SLP4560 | In distribution | |
| 63-CS-7530 | In distribution | |
| 63-CS-7545 | In distribution | |
| SLC8570 | In distribution | |
| SLPL8525 | In distribution | |
| SLPL8530 | In distribution | |
| SLPL4560 | In distribution | |
| PSS7550 | In distribution | |
| SLPL7550 | In distribution | |
| 63-CS-8590 | In distribution | |
| 63-CS-7555 | In distribution | |
| SLC6555 | In distribution | |
| SLP7555 | In distribution | |
| SLP4550 | In distribution | |
| SLP6530 | In distribution | |
| 63-CS-6525 | In distribution | |
| SLPL7545 | In distribution | |
| SLP5555 | In distribution | |
| SLPL4550 | In distribution | |
| SLC8590 | In distribution | |
| LAA5535 | In distribution | |
| 63-CS-7550 | In distribution | |
| SLPL5535 | In distribution | |
| SLP8555 | In distribution | |
| 63-CR-8530 | In distribution | |
| SLPL5540 | In distribution | |
| SLC7540 | In distribution | |
| SLPL4540 | In distribution | |
| 63-CR-8580 | In distribution | |
| SLP4535 | In distribution | |
| 63-CS-7540 | In distribution | |
| SLP6535 | In distribution | |
| 63-CR-5535 | In distribution | |
| SLP8550 | In distribution | |
| SLP7530 | In distribution | |
| 63-CR-6535 | In distribution | |
| SLC8545 | In distribution | |
| SLPL5555 | In distribution | |
| SLPL4530 | In distribution | |
| SLP4545 | In distribution | |
| 63-CS-6530 | In distribution | |
| SLP5550 | In distribution | |
| SLPL4525 | In distribution | |
| SLC8530 | In distribution | |
| SLP5560 | In distribution | |
| SLPL8580 | In distribution | |
| SLP8530 | In distribution | |
| SLPL8555 | In distribution | |
| SLC6540 | In distribution | |
| 63-CS-6540 | In distribution | |
| 63-CS-5545 | In distribution | |
| SLPL5550 | In distribution | |
| 110-5110 | In distribution | |
| 63-CR-7530 | In distribution | |
| SLPL7540 | In distribution | |
| SLPL8570 | In distribution | |
| SLPL4535 | In distribution | |
| 63-CS-8545 | In distribution | |
| SLP8590 | In distribution | |
| PSS5555 | In distribution | |
| SLP8535 | In distribution | |
| SLC8540 | In distribution | |
| SLC6560 | In distribution | |
| SLPL8560 | In distribution | |
| 63-CR-8500 | In distribution | |
| PSS6535 | In distribution | |
| 63-CS-8535 | In distribution | |
| 63-CR-5525 | In distribution | |
| SLP6550 | In distribution | |
| PSS5540 | In distribution | |
| 63-CR-8525 | In distribution | |
| SLPL7555 | In distribution | |
| SLC7555 | In distribution | |
| SLC8560 | In distribution | |
| 63-CR-6560 | In distribution | |
| SLP6560 | In distribution | |
| SLC7535 | In distribution | |
| LAA5550 | In distribution | |
| 63-CS-8580 | In distribution | |
| 63-CS-6535 | In distribution | |
| SLPL4555 | In distribution | |
| 63-CR-5530 | In distribution | |
| SLPL8545 | In distribution | |
| SLC6545 | In distribution | |
| SLC7560 | In distribution | |
| SLPL8100 | In distribution | |
| PSS7545 | In distribution | |
| 63-CR-5540 | In distribution | |
| 100-5540 | In distribution | |
| PSS7535 | In distribution | |
| 63-CR-5555 | In distribution | |
| SLP5545 | In distribution | |
| SLPL8535 | In distribution | |
| PSS5545 | In distribution | |
| SLC8525 | In distribution | |
| SLPL7535 | In distribution | |
| SLP7535 | In distribution | |
| SLC5545 | In distribution | |
| LAA6540 | In distribution | |
| SLPL5525 | In distribution | |
| 63-CR-8540 | In distribution | |
| SLPL6545 | In distribution | |
| SLPL8550 | In distribution | |
| 63-CS-7560 | In distribution | |
| SLP7525 | In distribution | |
| LAA6545 | In distribution | |
| SLC7550 | In distribution | |
| 63-CS-5560 | In distribution | |
| PSS6550 | In distribution | |
| 63-CS-5555 | In distribution | |
| 63-CR-7550 | In distribution | |
| 63-CS-8500 | In distribution | |
| 63-CR-7540 | In distribution | |
| SLC8555 | In distribution | |
| SLP8545 | In distribution | |
| 63-CS-8555 | In distribution | |
| 63-CS-8550 | In distribution | |
| 63-CS-8525 | In distribution | |
| SLPL6560 | In distribution | |
| SLPL5545 | In distribution | |
| 63-CR-7535 | In distribution | |
| SLP4540 | 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.