Malibu
Cannulated Uni-Planar Reduction Screw 6.0 DIA x 110mm
13manufacturers in China registered for this device type
186catalogue 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 | Seaspine, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2017-02-13 |
| Record revised | 2025-07-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2017-02-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18-7575 | Ø7.5 x 75mm | Withdrawn |
| 12-7065 | 7.0 x 65mm | Withdrawn |
| 18-5545 | 5.5mm x 45mm | Withdrawn |
| 13-5030 | 5.0 x 30mm | Withdrawn |
| 73-7065 | 7.0 DIA x 65mm | Withdrawn |
| 16-7555 | 7.5 x 55mm | Withdrawn |
| 74-6045 | 6.0 DIA x 45mm | Withdrawn |
| 18-6545 | 6.5mm x 45mm | Withdrawn |
| 74-6590 | 6.5 DIA x 90mm | Withdrawn |
| 74-6530 | 6.5 DIA x 30mm | Withdrawn |
| 74-6540 | 6.5 DIA x 40mm | Withdrawn |
| 12-6035 | 6.0 x 35mm | Withdrawn |
| 74-6035 | 6.0 DIA x 35mm | Withdrawn |
| 18-7040 | Ø7.0 x 40mm | Withdrawn |
| 12-0020 | 8 | Withdrawn |
| 13-6505 | 6.5 x 105mm | Withdrawn |
| 13-7070 | 7.0 x 70mm | Withdrawn |
| 12-6570 | 6.5 x 70mm | Withdrawn |
| 12-7500 | 7.5 x 100mm | Withdrawn |
| 68-6570 | 6.5 DIA x 70mm | Withdrawn |
| 13-7555 | 7.5 x 55mm | Withdrawn |
| 16-9545 | 9.5 x 45mm | Withdrawn |
| 13-8030 | 8.0 x 30mm | Withdrawn |
| 12-5525 | 5.5 x 25mm | Withdrawn |
| 12-7045 | 7.0 x 45mm | Withdrawn |
| 13-6555 | 6.5 x 55mm | Withdrawn |
| 68-6550 | 6.5 DIA x 50mm | Withdrawn |
| 18-7070 | Ø7.0 x 70mm | Withdrawn |
| 68-6580 | 6.5 DIA x 80mm | Withdrawn |
| 13-7595 | 7.5 x 95mm | Withdrawn |
| 74-6025 | 6.0 DIA x 25mm | Withdrawn |
| 13-8040 | 8.0 x 40mm | Withdrawn |
| 68-7055 | 7.0 DIA x 55mm | Withdrawn |
| 12-7560 | 7.5 x 60mm | Withdrawn |
| 68-7065 | 7.0 DIA x 65mm | Withdrawn |
| 18-6040 | Ø6.0 x 40mm | Withdrawn |
| 13-5040 | 5.0 x 40mm | Withdrawn |
| 12-7530 | 7.5 x 30mm | Withdrawn |
| 12-8590 | 8.5 x 90mm | Withdrawn |
| 68-6560 | 6.5 DIA x 60mm | Withdrawn |
| 18-7535 | Ø7.5 x 35mm | Withdrawn |
| 18-7050 | Ø7.0 x 50mm | Withdrawn |
| 73-7535 | 7.5 DIA x 35mm | Withdrawn |
| 12-4555 | 4.5 x 55mm | Withdrawn |
| 68-6540 | 6.5 DIA x 40mm | Withdrawn |
| 12-8560 | 8.5 x 60mm | Withdrawn |
| 12-8540 | 8.5 x 40mm | Withdrawn |
| 12-8035 | 8.0 x 35mm | Withdrawn |
| 12-8095 | 8.0 x 95mm | Withdrawn |
| 13-7535 | 7.5 x 35mm | Withdrawn |
| 12-7025 | 7.0 x 25mm | Withdrawn |
| 73-7545 | 7.5 DIA x 45mm | Withdrawn |
| 12-6540 | 6.5 x 40mm | Withdrawn |
| 16-9555 | 9.5 x 55mm | Withdrawn |
| 12-8505 | 8.5 x 105mm | Withdrawn |
| 13-5550 | 5.5 x 50mm | Withdrawn |
| 12-8550 | 8.5 x 50mm | Withdrawn |
| 12-6045 | 6.0 x 45mm | Withdrawn |
| 12-8010 | 8.0 x 110mm | Withdrawn |
| 13-4530 | 4.5 x 30mm | Withdrawn |
| 18-6060 | Ø6.0 x 60mm | Withdrawn |
| 13-8080 | 8.0 x 80mm | Withdrawn |
| 74-6580 | 6.5 DIA x 80mm | Withdrawn |
| 13-7050 | 7.0 x 50mm | Withdrawn |
| 12-7570 | 7.5 x 70mm | Withdrawn |
| 18-6565 | Ø6.5 x 65mm | Withdrawn |
| 74-6560 | 6.5 DIA x 60mm | Withdrawn |
| 12-8580 | 8.5 x 80mm | Withdrawn |
| 74-7025 | 7.0 DIA x 25mm | Withdrawn |
| 12-7590 | 7.5 x 90mm | Withdrawn |
| 73-7525 | 7.5 DIA x 25mm | Withdrawn |
| 12-5025 | 5.0 x 25mm | Withdrawn |
| 74-6055 | 6.0 DIA x 55mm | Withdrawn |
| 13-8050 | 8.0 x 50mm | Withdrawn |
| 12-8065 | 8.0 x 65mm | Withdrawn |
| 13-8005 | 8.0 x 105mm | Withdrawn |
| 74-6510 | 6.0 DIA x 110mm | Withdrawn |
| 12-8530 | 8.5 x 30mm | Withdrawn |
| 18-5555 | Ø5.5 x 55mm | Withdrawn |
| 75-7035 | Ø7.0 x 35mm | Withdrawn |
| 13-7565 | 7.5 x 65mm | Withdrawn |
| 73-6590 | 6.5 DIA x 90mm | Withdrawn |
| 13-8090 | 8.0 x 90mm | Withdrawn |
| 13-6050 | 6.0 x 50mm | Withdrawn |
| 13-6030 | 6.0 x 30mm | Withdrawn |
| 12-7055 | 7.0 x 55mm | Withdrawn |
| 12-5055 | 5.0 x 55mm | Withdrawn |
| 12-4545 | 4.5 x 45mm | Withdrawn |
| 16-7545 | 7.5 x 45mm | Withdrawn |
| 74-6570 | 6.5 DIA x 70mm | Withdrawn |
| 13-5050 | 5.0 x 50mm | Withdrawn |
| 68-6590 | 6.5 DIA x 90mm | Withdrawn |
| 74-5555 | 5.5 DIA x 55mm | Withdrawn |
| 13-7585 | 7.5 x 85mm | Withdrawn |
| 16-7535 | 7.5 x 35mm | Withdrawn |
| 16-5550 | 5.5 x 50mm | Withdrawn |
| 73-7055 | 7.0 DIA x 55mm | Withdrawn |
| 13-6040 | 6.0 x 40mm | Withdrawn |
| 12-6530 | 6.5 x 30mm | Withdrawn |
| 18-5535 | Ø5.5 x 35mm | Withdrawn |
| 12-6055 | 6.0 x 55mm | Withdrawn |
| 12-8085 | 8.0 x 85mm | Withdrawn |
| 74-5535 | 5.5 DIA x 35mm | Withdrawn |
| 12-6580 | 6.5 x 80mm | Withdrawn |
| 13-6060 | 6.0 x 60mm | Withdrawn |
| 12-5555 | 5.5 x 55mm | Withdrawn |
| 13-6565 | 6.5 x 65mm | Withdrawn |
| 13-7505 | 7.5 x 105mm | Withdrawn |
| 73-7565 | 7.5 DIA x 65mm | Withdrawn |
| 12-8075 | 8.0 x 75mm | Withdrawn |
| 74-6550 | 6.5 DIA x 50mm | Withdrawn |
| 12-6590 | 6.5 x 90mm | Withdrawn |
| 12-7580 | 7.5 x 80mm | Withdrawn |
| 12-5045 | 5.0 x 45mm | Withdrawn |
| 73-7035 | 7.0 DIA x 35mm | Withdrawn |
| 18-7565 | Ø7.5 x 65mm | Withdrawn |
| 18-7060 | Ø7.0 x 60mm | Withdrawn |
| 74-5545 | 5.5 DIA x 45mm | Withdrawn |
| 13-5060 | 5.0 x 60mm | Withdrawn |
| 13-4520 | 4.5 x 20mm | Withdrawn |
| 18-6050 | Ø6.0 x 50mm | Withdrawn |
| 16-6550 | 6.5 x 50mm | Withdrawn |
| 68-7035 | 7.0 DIA x 35mm | Withdrawn |
| 13-7030 | 7.0 x 30mm | Withdrawn |
| 16-8540 | 8.5 x 40mm | Withdrawn |
| 12-6510 | 6.5 x 110mm | Withdrawn |
| 18-6535 | 6.5mm x 35mm | Withdrawn |
| 13-5540 | 5.5 x 40mm | Withdrawn |
| 13-7040 | 7.0 x 40mm | Withdrawn |
| 13-7060 | 7.0 x 60mm | Withdrawn |
| 18-5525 | Ø5.5 x 25mm | Withdrawn |
| 18-7555 | Ø7.5 x 55mm | Withdrawn |
| 75-6590 | Ø6.5 x 90mm | Withdrawn |
| 12-8570 | 8.5 x 70mm | Withdrawn |
| 13-4540 | 4.5 x 40mm | Withdrawn |
| 13-4550 | 4.5 x 50mm | Withdrawn |
| 12-4535 | 4.5 x 35mm | Withdrawn |
| 16-8550 | 8.5 x 50mm | Withdrawn |
| 12-5545 | 5.5 x 45mm | Withdrawn |
| 12-6500 | 6.5 x 100mm | Withdrawn |
| 12-5035 | 5.0 x 35mm | Withdrawn |
| 12-7035 | 7.0 x 35mm | Withdrawn |
| 73-7025 | 7.0 DIA x 25mm | Withdrawn |
| 13-6595 | 6.5 x 95mm | Withdrawn |
| 13-7575 | 7.5 x 75mm | Withdrawn |
| 73-6580 | 6.5 DIA x 80mm | Withdrawn |
| 13-5530 | 5.5 x 30mm | Withdrawn |
| 16-5530 | 5.5 x 30mm | Withdrawn |
| 18-7545 | 7.5mm x 45mm | Withdrawn |
| 13-4560 | 4.5 x 60mm | Withdrawn |
| 13-6585 | 6.5 x 85mm | Withdrawn |
| 12-7540 | 7.5 x 40mm | Withdrawn |
| 12-6560 | 6.5 x 60mm | Withdrawn |
| 68-7045 | 7.0 DIA x 45mm | Withdrawn |
| 13-5560 | 5.5 x 60mm | Withdrawn |
| 74-5525 | 5.5 DIA x 25mm | Withdrawn |
| 12-7510 | 7.5 x 110mm | Withdrawn |
| 13-8060 | 8.0 x 60mm | Withdrawn |
| 16-0015 | Withdrawn | |
| 18-7030 | Ø7.0 x 30mm | Withdrawn |
| 12-7550 | 7.5 x 50mm | Withdrawn |
| 12-6550 | 6.5 x 50mm | Withdrawn |
| 12-8000 | 8.0 x 100mm | Withdrawn |
| 12-6025 | 6.0 x 25mm | Withdrawn |
| 13-6535 | 6.5 x 35mm | Withdrawn |
| 18-6555 | Ø6.5 x 55mm | Withdrawn |
| 13-6545 | 6.5 x 45mm | Withdrawn |
| 73-7045 | 7.0 DIA x 45mm | Withdrawn |
| 16-5540 | 5.5 x 40mm | Withdrawn |
| 16-6540 | 6.5 x 40mm | Withdrawn |
| 13-6525 | 6.5 x 25mm | Withdrawn |
| 75-7025 | Ø7.0 x 25mm | Withdrawn |
| 18-6030 | Ø6.0 x 30mm | Withdrawn |
| 13-6575 | 6.5 x 75mm | Withdrawn |
| 73-7575 | 7.5 DIA x 75mm | Withdrawn |
| 68-7025 | 7.0 DIA x 25mm | Withdrawn |
| 12-5535 | 5.5 x 35mm | Withdrawn |
| 74-6500 | 6.0 DIA x 100mm | Withdrawn |
| 12-4525 | 4.5 x 25mm | Withdrawn |
| 16-9535 | 9.5 x 35mm | Withdrawn |
| 13-8070 | 8.0 x 70mm | Withdrawn |
| 13-7525 | 7.5 x 25mm | Withdrawn |
| 13-7545 | 7.5 x 45mm | Withdrawn |
| 12-8045 | 8.0 x 45mm | Withdrawn |
| 12-8055 | 8.0 x 55mm | Withdrawn |
| 73-7555 | 7.5 DIA x 55mm | Withdrawn |
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.