Ballista Percutaneous Pedicle Screw System
31 catalogue numbers from 2000-3455E, listed by Biomet Spine, United States, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
31catalogue 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 | Biomet Spine, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2000-3455E | 6.5 X 55MM CANNULATED SCREW | In distribution |
| 2000-5275 | 75MM PERCUTANEOUS ROD | In distribution |
| 2000-3525 | 7.5X 25MM CANNULATED SCREW | In distribution |
| 2000-5245 | 45MM PERCUTANEOUS ROD | In distribution |
| 2000-3425 | 6.5X 25MM CANNULATED SCREW | In distribution |
| 2000-3755 | 9.5X 55MM CANNULATED SCREW | In distribution |
| 2000-3695 | 8.5X 95MM CANNULATED SCREW | In distribution |
| 2000-3445 | 6.5X 45MM CANNUALTED SCREW | In distribution |
| 2000-3335 | 5.5X 35MM CANNULATED SCREW | In distribution |
| 2000-3820 | 10.5X 20MM CANNULATED SCREW | In distribution |
| 2000-5290 | 90MM PERCUTANEOUS ROD | In distribution |
| 2000-3575 | 7.5X 75MM CANNULATED SCREW | In distribution |
| 2000-3375 | 5.5X 75MM CANNULATED SCREW | In distribution |
| 2000-3680 | 8.5X 80MM CANNULATED SCREW | In distribution |
| 2000-3350E | 5.5 X 50MM CANNULATED SCREW | In distribution |
| 2000-3840 | 10.5X 40MM CANNULATED SCREW | In distribution |
| 2000-3645 | 8.5X 45MM CANNULATED SCREW | In distribution |
| 2000-3750 | 9.5X 50MM CANNULATED SCREW | In distribution |
| 2000-3530 | 7.5X 30MM CANNULATED SCREW | In distribution |
| 2000-3435 | 6.5X 35MM CANNULATED SCREW | In distribution |
| 2000-3799 | 9.5X 100MM CANNULATED SCREW | In distribution |
| 2000-3570 | 7.5X 70MM CANNULATED SCREW | In distribution |
| 2000-5270 | 70MM PERCUTANEOUS ROD | In distribution |
| 2000-3390 | 5.5X 90MM CANNULATED SCREW | In distribution |
| 2000-3440 | 6.5X 40MM CANNULATED SCREW | In distribution |
| 2000-3340 | 5.5X 40MM CANNULATED SCREW | In distribution |
| 2000-5295 | 95MM PERCUTANEOUS ROD | In distribution |
| 2000-5230 | 30MM PERCUTANEOUS ROD | In distribution |
| 2000-3770 | 9.5X 70MM CANNULATED SCREW | In distribution |
| 2000-3735 | 9.5X 35MM CANNULATED SCREW | In distribution |
| 2000-3655 | 8.5X 55MM CANNULATED SCREW | 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.