MEGA5.5 Spine System
Multi-axial Long-arm Screw, Ø6.0 x 35mm
13manufacturers in China registered for this device type
83catalogue 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) | K123476 |
| Record published | 2015-09-22 |
| Record revised | 2025-07-14 (version 6) |
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 |
|---|---|---|
| 63525-55 | In distribution | |
| 63517-45 | In distribution | |
| 82130-170 | In distribution | |
| 63526-30 | In distribution | |
| 82130-045 | In distribution | |
| 82120-22 | In distribution | |
| 63525-45 | In distribution | |
| 63545-35 | In distribution | |
| 63544-30 | In distribution | |
| 63515-35 | In distribution | |
| 63520 | In distribution | |
| 82120-40 | In distribution | |
| 82120-15 | In distribution | |
| 82120-19 | In distribution | |
| 63545-55 | In distribution | |
| 63534-30 | In distribution | |
| 63524-50 | In distribution | |
| 63546-40 | In distribution | |
| 63527-55 | In distribution | |
| 82130-055 | In distribution | |
| 63534-40 | In distribution | |
| 82130-090 | In distribution | |
| 82130-150 | In distribution | |
| 63517-55 | In distribution | |
| 82130-035 | In distribution | |
| 63534-60 | In distribution | |
| 63516-30 | In distribution | |
| 63517-35 | In distribution | |
| 82130-075 | In distribution | |
| 63526-50 | In distribution | |
| 63527-45 | In distribution | |
| 63514-40 | In distribution | |
| 82310-50 | In distribution | |
| 82120-04 | In distribution | |
| 82120-28 | In distribution | |
| 63516-40 | In distribution | |
| 63546-60 | In distribution | |
| 63544-60 | In distribution | |
| 63526-40 | In distribution | |
| 63536-60 | In distribution | |
| 63534-50 | In distribution | |
| 63524-30 | In distribution | |
| 82120-17 | In distribution | |
| 63526-60 | In distribution | |
| 63537-35 | In distribution | |
| 63516-50 | In distribution | |
| 63514-60 | In distribution | |
| 82120-11 | In distribution | |
| 63535-55 | In distribution | |
| 63515-55 | In distribution | |
| 82120-09 | In distribution | |
| 82130-065 | In distribution | |
| 63546-50 | In distribution | |
| 82310-40 | In distribution | |
| 63545-45 | In distribution | |
| 63537-55 | In distribution | |
| 63547-35 | In distribution | |
| 82130-110 | In distribution | |
| 82120-25 | In distribution | |
| 63546-30 | In distribution | |
| 63514-30 | In distribution | |
| 63515-45 | In distribution | |
| 63536-50 | In distribution | |
| 63537-45 | In distribution | |
| 63527-35 | In distribution | |
| 63524-60 | In distribution | |
| 82130-130 | In distribution | |
| 82120-13 | In distribution | |
| 63514-50 | In distribution | |
| 63535-45 | In distribution | |
| 63536-40 | In distribution | |
| 63535-35 | In distribution | |
| 63516-60 | In distribution | |
| 63547-55 | In distribution | |
| 82120-07 | In distribution | |
| 63547-45 | In distribution | |
| 63536-30 | In distribution | |
| 63525-35 | In distribution | |
| 82120-05 | In distribution | |
| 63524-40 | In distribution | |
| 82130-190 | In distribution | |
| 63544-40 | In distribution | |
| 63544-50 | 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.