PressON Pedicle Screw System
MIS Pedicle Screw 6.5 x 45mm, Cannulated
13manufacturers in China registered for this device type
42catalogue 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 | Nexus Spine, L.L.C., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K160820 |
| Record published | 2025-12-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 12 to 60 mm; width 5.5 to 8.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 520287S | Length 30 mm | In distribution |
| 520278S | Length 12 mm | In distribution |
| 520226S | Width 6.5 mm | In distribution |
| 520224S | Width 6.5 mm | In distribution |
| 520221S | Width 5.5 mm | In distribution |
| 520217S | Width 5.5 mm | In distribution |
| 520231S | Width 7.5 mm | In distribution |
| 520232S | Width 7.5 mm | In distribution |
| 520285S | Length 26 mm | In distribution |
| 520223S | Width 6.5 mm | In distribution |
| 520289S | Length 34 mm | In distribution |
| 520240S | Width 8.5 mm | In distribution |
| 520215S | Width 5.5 mm | In distribution |
| 520227S | Width 6.5 mm | In distribution |
| 520291S | Length 39 mm | In distribution |
| 520220S | Width 5.5 mm | In distribution |
| 520239S | Width 8.5 mm | In distribution |
| 520295S | Length 51 mm | In distribution |
| 520218S | Width 5.5 mm | In distribution |
| 520294S | Length 48 mm | In distribution |
| 520290S | Length 36 mm | In distribution |
| 520225S | Width 6.5 mm | In distribution |
| 520216S | Width 5.5 mm | In distribution |
| 520235S | Width 7.5 mm | In distribution |
| 520282S | Length 20 mm | In distribution |
| 520284S | Length 24 mm | In distribution |
| 520296S | Length 54 mm | In distribution |
| 520292S | Length 42 mm | In distribution |
| 520228S | Width 6.5 mm | In distribution |
| 520283S | Length 22 mm | In distribution |
| 520281S | Length 18 mm | In distribution |
| 520241S | Width 8.5 mm | In distribution |
| 520280S | Length 16 mm | In distribution |
| 520236S | Width 7.5 mm | In distribution |
| 520293S | Length 45 mm | In distribution |
| 520219S | Width 5.5 mm | In distribution |
| 520233S | Width 7.5 mm | In distribution |
| 520234S | Width 7.5 mm | In distribution |
| 520286S | Length 28 mm | In distribution |
| 520279S | Length 14 mm | In distribution |
| 520288S | Length 32 mm | In distribution |
| 520230S | Width 7.5 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.