MD-Max Ulif
MD-Max™ Triple Lead System Implant Tray - Empty
13manufacturers in China registered for this device type
73catalogue 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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K122931 |
| Record published | 2019-05-10 |
| Record revised | 2025-11-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 43-TL-1030 | In distribution | |
| 43-7000-6560 | In distribution | |
| 43-8050 | In distribution | |
| 43-7000-8550 | In distribution | |
| 43-8600 | In distribution | |
| 43-TL-5545 | In distribution | |
| 43-7000-8555 | In distribution | |
| 43-TL-7550 | In distribution | |
| 43-TL-8560 | In distribution | |
| 43-7000-7545 | In distribution | |
| 43-7000-7540 | In distribution | |
| 43-7000-6545 | In distribution | |
| 43-7000-5530 | In distribution | |
| 43-TL-7525 | In distribution | |
| 43-7000-6555 | In distribution | |
| 43-TL-1035 | In distribution | |
| 43-TL-7555 | In distribution | |
| 43-TL-7540 | In distribution | |
| 43-TL-9512 | In distribution | |
| 43-TL-9511 | In distribution | |
| 43-TL-7560 | In distribution | |
| 43-TL-1090 | In distribution | |
| 43-7000-7535 | In distribution | |
| 43-TL-7535 | In distribution | |
| 43-7000-8525 | In distribution | |
| 43-7000-8530 | In distribution | |
| 43-TL-1055 | In distribution | |
| 43-TL-9500 | In distribution | |
| 43-TL-5560 | In distribution | |
| 43-7000-7530 | In distribution | |
| 43-TL-8545 | In distribution | |
| 43-7000-6550 | In distribution | |
| 43-TL-9535 | In distribution | |
| 43-TL-6535 | In distribution | |
| 43-TL-8570 | In distribution | |
| 43-7000-7550 | In distribution | |
| 43-7000-5555 | In distribution | |
| 43-TL-9555 | In distribution | |
| 43-7000-8590 | In distribution | |
| 43-TL-5530 | In distribution | |
| 43-7000-7525 | In distribution | |
| 43-7000-5535 | In distribution | |
| 43-7000-6535 | In distribution | |
| 43-7000-5545 | In distribution | |
| 43-TL-6555 | In distribution | |
| 43-TL-8580 | In distribution | |
| 43-TL-5535 | In distribution | |
| 43-7000-7555 | In distribution | |
| 43-7000-5525 | In distribution | |
| 43-7000-8535 | In distribution | |
| 43-TL-8535 | In distribution | |
| 43-TL-6550 | In distribution | |
| 43-TL-9590 | In distribution | |
| 43-TL-9540 | In distribution | |
| 43-TL-7545 | In distribution | |
| 43-TL-1070 | In distribution | |
| 43-TL-8525 | In distribution | |
| 43-7000-5560 | In distribution | |
| 43-TL-9525 | In distribution | |
| 43-TL-8590 | In distribution | |
| 43-TL-5555 | In distribution | |
| 43-TL-1025 | In distribution | |
| 43-7000-6530 | In distribution | |
| 43-TL-8540 | In distribution | |
| 43-TL-6540 | In distribution | |
| 43-TL-7530 | In distribution | |
| 43-7000-7560 | In distribution | |
| 43-TL-9530 | In distribution | |
| 43-8600-CA | In distribution | |
| 43-TL-1000 | In distribution | |
| 43-7000-5550 | In distribution | |
| 43-TL-9550 | In distribution | |
| 43-TL-1011 | 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.