Percusys®
Percusys® Pedicle Screw polyaxial OD 6 x 50 mm, incl. Set Screw
13manufacturers in China registered for this device type
34catalogue 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, Spinal Pedicle Fixation
Record
| Listed by | Joimax Gmbh, Germany |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K143200 |
| Record published | 2015-09-24 |
| Record revised | 2025-01-08 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| JMPS0650PS | In distribution | |
| JMPS0755MS | In distribution | |
| JMPS0645MS | In distribution | |
| JMPS0740MS | In distribution | |
| JMPS0650MS | In distribution | |
| JMPS0735PS | In distribution | |
| JMPS0640MS | In distribution | |
| JMPS0655PS | In distribution | |
| JMPS0655MS | In distribution | |
| JMPS0030RL | In distribution | |
| JMPS0735MS | In distribution | |
| JMPS0550MS | In distribution | |
| JMPS0750PS | In distribution | |
| JMPS0545MS | In distribution | |
| JMPS0755PS | In distribution | |
| JMPS0550PS | In distribution | |
| JMPS0855MS | In distribution | |
| JMPS0855PS | In distribution | |
| JMPS0835MS | In distribution | |
| JMPS0645PS | In distribution | |
| JMPS0840MS | In distribution | |
| JMPS0640PS | In distribution | |
| JMPS0635MS | In distribution | |
| JMPS0840PS | In distribution | |
| JMPS0740PS | In distribution | |
| JMPS0750MS | In distribution | |
| JMPS0850MS | In distribution | |
| JMPS0850PS | In distribution | |
| JMPS0845MS | In distribution | |
| JMPS0845PS | In distribution | |
| JMPS0635PS | In distribution | |
| JMPS0545PS | In distribution | |
| JMPS0835PS | In distribution | |
| JMPS0745MS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle 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.