Radius
Cross Connector, Variable M-A Curved, Extra Extra Long
13manufacturers in China registered for this device type
52catalogue 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2014-12-08 |
| Record revised | 2024-09-11 (version 9) |
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, manufacturing date |
| Sizes | Length 19 to 360 mm; angle 75 ° |
| Distribution end date | 2024-06-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 486615180 | Diameter: 5.5 Millimeter | In distribution |
| 486613200 | Length 200.0 mm | In distribution |
| 486614130 | In distribution | |
| 486613009 | Length 90.0 mm | In distribution |
| 486613140 | Length 140.0 mm | In distribution |
| 486613360 | Diameter: 5.5 Millimeter | In distribution |
| 486613280 | Diameter: 5.5 Millimeter | In distribution |
| 486615090 | Length 90.0 mm | In distribution |
| 486613003 | Diameter: 5.5 Millimeter | In distribution |
| 486614300 | Degree: 0.0 Degree | In distribution |
| 486614375 | Angle 75.0 ° | In distribution |
| 486614160 | In distribution | |
| 486614129 | In distribution | |
| 486613300 | Diameter: 5.5 Millimeter | In distribution |
| 486614310 | In distribution | |
| 486614022 | Length 22.0 mm | In distribution |
| 486614140 | In distribution | |
| 486615590 | Length 90.0 mm | In distribution |
| 486614028 | Length 28.0 mm | In distribution |
| 486613008 | Diameter: 5.5 Millimeter | In distribution |
| 486610600 | Diameter: 6.75 Millimeter | Withdrawn |
| 486611440 | Diameter: 4.75 Millimeter | Withdrawn |
| 486616000 | Withdrawn | |
| 486618670 | Diameter: 6.75 Millimeter | Withdrawn |
| 486616021 | Withdrawn | |
| 486616001 | Withdrawn | |
| 486611700 | Length 100.0 mm | Withdrawn |
| 486611340 | Diameter: 4.0 Millimeter | Withdrawn |
| 486611325 | Length 25.0 mm | Withdrawn |
| 486610765 | Diameter: 7.75 Millimeter | Withdrawn |
| 486612535 | Length 35.0 mm | Withdrawn |
| 486611660 | Diameter: 6.75 Millimeter | Withdrawn |
| 486610780 | Diameter: 7.75 Millimeter | Withdrawn |
| 486616003 | Withdrawn | |
| 486618550 | Diameter: 5.75 Millimeter | Withdrawn |
| 486610770 | Length 70.0 mm | Withdrawn |
| 486618535 | Length 35.0 mm | Withdrawn |
| 486611430 | Diameter: 4.75 Millimeter | Withdrawn |
| 486611680 | Diameter: 6.75 Millimeter | Withdrawn |
| 486610790 | Diameter: 7.75 Millimeter | Withdrawn |
| 486616002 | Withdrawn | |
| 486618725 | Diameter: 7.75 Millimeter | Withdrawn |
| 486614219 | Length 19.0 mm | Withdrawn |
| 486612755 | Length 55.0 mm | Withdrawn |
| 486610700 | Length 100.0 mm | Withdrawn |
| 486612635 | Length 35.0 mm | Withdrawn |
| 486611940 | Diameter: 9.75 Millimeter | Withdrawn |
| 486611800 | Diameter: 8.75 Millimeter | Withdrawn |
| 486611630 | Length 30.0 mm | Withdrawn |
| 486611330 | Diameter: 4.0 Millimeter | Withdrawn |
| 486618530 | Length 30.0 mm | Withdrawn |
| 486616018 | 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.