Ballista™ Percutaneous
46 catalogue numbers from 14-500440, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
46catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2020-06-23 |
| Record revised | 2025-01-03 (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 |
|---|---|---|
| 14-500440 | 40MM PERCUTANEOUS ROD, CURVED PEDICLE SCREW SYSTEM | In distribution |
| 14-500470 | 70MM PERCUTANEOUS ROD, CURVED PEDICLE SCREW SYSTEM | In distribution |
| 14-500499 | 100MM PERCUTANEOUS ROD, CURVED PEDICLE SCREW SYSTEM | In distribution |
| 14-500480 | 80MM PERCUTANEOUS ROD, CURVED PEDICLE SCREW SYSTEM | In distribution |
| 2000-3545 | 7.5X 45MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500650E | 50 MM BALLISTA ROD, SMOOTH | In distribution |
| 2000-3785 | 9.5X 85MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3875 | 10.5X 75MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500625 | 25MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 2000-3490 | 6.5X 90MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3335E | 5.5 X 35 MM CANNULATED SCREW | In distribution |
| 2000-3450 | 6.5X 50MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-5275 | 75MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
| 14-500670E | 70 MM BALLISTA ROD, SMOOTH | In distribution |
| 2000-3540E | 7.5 X 40 MM CANNULATED SCREW | In distribution |
| 2000-3450E | 6.5 X 50 MM CANNULATED SCREW | In distribution |
| 2000-3560E | 7.5 X 60 MM CANNULATED SCREW | In distribution |
| 2000-3580 | 7.5X 80MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3350 | 5.5X 50MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500445 | 45MM PERCUTANEOUS ROD, CURVED PEDICLE SCREW SYSTEM | In distribution |
| 14-500425E | 25 MM PERCUTANEOUS ROD, CURVED | In distribution |
| 14-500435E | 35 MM PERCUTANEOUS ROD, CURVED | In distribution |
| 14-500475E | 75 MM PERCUTANEOUS ROD, CURVED | In distribution |
| 2000-6904 | BLUNT GUIDEWIRE 1.6MM X 510MM PEDICLE SCREW SYSTEM | In distribution |
| 2000-3585 | 7.5X 85MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3690 | 8.5X 90MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3355E | 5.5 X 55 MM CANNULATED SCREW | In distribution |
| 2000-3430 | 6.5X 30MM CANNUALTED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3390 | 5.5X 90MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3830 | 10.5X 30MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3840 | 10.5X 40MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500690E | 90 MM BALLISTA ROD, SMOOTH | In distribution |
| 14-500699 | 100MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 2000-3750 | 9.5X 50MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3735 | 9.5X 35MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500680 | 80MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 2000-3880 | 10.5X 80MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3485 | 6.5X 85MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3470 | 6.5X 70MM CANNUALTED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3660 | 8.5X 60MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500690 | 90MM BALLISTA ROD, SMOOTH PEDICLE SCREW SYSTEM | In distribution |
| 2000-3765 | 9.5X 65MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 14-500499E | 100 MM PERCUTANEOUS ROD, CURVED | In distribution |
| 2000-3845 | 10.5X 45MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-3599 | 7.5X 100MM CANNULATED SCREW PEDICLE SCREW SYSTEM | In distribution |
| 2000-5290 | 90MM PERCUTANEOUS ROD PEDICLE SCREW SYSTEM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.