Mega Spine System
Multi-axial Screw, Ø6.5 x 40mm
13manufacturers in China registered for this device type
38catalogue numbers in this listing
1510(k) clearance
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 | BK Meditech Co., Ltd., South Korea |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K072436 |
| Record published | 2015-09-22 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 61265-40 | In distribution | |
| 61265-50 | In distribution | |
| 61165-45 | In distribution | |
| 61175-50 | In distribution | |
| 61510-40 | In distribution | |
| 61360-50 | In distribution | |
| 61120-10 | In distribution | |
| 61260-45 | In distribution | |
| 61260-35 | In distribution | |
| 61355-40 | In distribution | |
| 61175-40 | In distribution | |
| 61365-45 | In distribution | |
| 61360-30 | In distribution | |
| 61120-16 | In distribution | |
| 61175-30 | In distribution | |
| 61160-40 | In distribution | |
| 61160-30 | In distribution | |
| 61120-04 | In distribution | |
| 61155-40 | In distribution | |
| 61120-40 | In distribution | |
| 61275-45 | In distribution | |
| 61365-35 | In distribution | |
| 61255-45 | In distribution | |
| 61265-30 | In distribution | |
| 61510-50 | In distribution | |
| 61375-40 | In distribution | |
| 61375-50 | In distribution | |
| 61120-08 | In distribution | |
| 61375-30 | In distribution | |
| 61155-30 | In distribution | |
| 61255-35 | In distribution | |
| 61165-35 | In distribution | |
| 61360-40 | In distribution | |
| 61120-06 | In distribution | |
| 61275-35 | In distribution | |
| 61120-12 | In distribution | |
| 61355-30 | In distribution | |
| 61160-50 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072436 | 2007-11-01 |
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.