Ballista™ Percutaneous
41 catalogue numbers from 14-500425, 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
41catalogue 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 | 2020-06-23 |
| Record revised | 2025-07-02 (version 5) |
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 |
|---|---|---|
| 14-500425 | 25MM PERCUTANEOUS ROD, CURVED PEDICLE SCREW SYSTEM | In distribution |
| 2000-3325 | 5.5X 25MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500450E | 50 MM PERCUTANEOUS ROD, CURVED | In distribution |
| 2000-3665 | 8.5X 65MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500650 | 50MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 14-500460E | 60 MM PERCUTANEOUS ROD, CURVED | In distribution |
| 2000-5295 | 95MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 2000-3820 | 10.5X 20MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3340 | 5.5X 40MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500475 | 75MM PERCUTANEOUS ROD, CURVED PEDICLE SCREW SYSTEM | In distribution |
| 2000-5235 | 35MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 14-500635 | 35MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 14-500435 | 35MM PERCUTANEOUS ROD, CURVED PEDICLE SCREW SYSTEM | In distribution |
| 14-500640E | 40 MM BALLISTA ROD, SMOOTH | In distribution |
| 2000-3360 | 5.5X 60MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-5250 | 50MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 2000-3355 | 5.5X 55MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3790 | 9.5X 90MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500645 | 45MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 14-500460 | 60MM PERCUTANEOUS ROD, CURVED PEDICLE SCREW SYSTEM | In distribution |
| 2000-3455 | 6.5X 55MM CANNUALTED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3455E | 6.5 X 55 MM CANNULATED SCREW | In distribution |
| 2000-3460E | 6.5 X 60 MM CANNULATED SCREW | In distribution |
| 14-500645E | 45 MM BALLISTA ROD, SMOOTH | In distribution |
| 2000-3555E | 7.5 X 55 MM CANNULATED SCREW | In distribution |
| 2000-3895 | 10.5X 95MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3835 | 10.5X 35MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3565 | 7.5X 65MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-5280 | 80MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 2000-3535 | 7.5X 35MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3650 | 8.5X 50MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3465 | 6.5X 65MM CANNUALTED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3630 | 8.5X 30MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3670 | 8.5X 70MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3855 | 10.5X 55MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3745 | 9.5X 45MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3595 | 7.5X 95MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3335 | 5.5X 35MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500630E | 30 MM BALLISTA ROD, SMOOTH | In distribution |
| 14-500665 | 65MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 2000-3395 | 5.5X 95MM CANNULATED SCREW PEDICLE SCREW SYSTEM | 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.