Spinal Instrument
Final tightening torque limited handle
13manufacturers in China registered for this device type
48catalogue 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 | Clariance, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K153326 |
| Record published | 2018-05-22 |
| Record revised | 2018-07-06 (version 2) |
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, manufacturing date |
| Sizes | Outer diameter 4.5 to 10.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 99781310 | In distribution | |
| 99743003 | In distribution | |
| 99701585 | Outer Diameter 8.5 mm | In distribution |
| 99701568 | Outer Diameter 6.8 mm | In distribution |
| 99701655 | Outer Diameter 5.5 mm | In distribution |
| 99701775 | Outer Diameter 7.5 mm | In distribution |
| 99781000 | In distribution | |
| 99701795 | Outer Diameter 9.5 mm | In distribution |
| 99701675 | Outer Diameter 7.5 mm | In distribution |
| 99701085 | Outer Diameter 8.5 mm | In distribution |
| 99782001 | In distribution | |
| 99731004 | In distribution | |
| 99782005 | In distribution | |
| 99701410 | Outer Diameter 10.5 mm | In distribution |
| 99781100 | In distribution | |
| 99715007 | In distribution | |
| 99719000 | In distribution | |
| 99701565 | Outer Diameter 6.5 mm | In distribution |
| 99702003 | In distribution | |
| 99701710 | Outer Diameter 10.5 mm | In distribution |
| 99750001 | In distribution | |
| 99780101 | In distribution | |
| 99782003 | In distribution | |
| 99715011 | In distribution | |
| 99781202 | In distribution | |
| 99740002 | In distribution | |
| 99701065 | Outer Diameter 6.5 mm | In distribution |
| 99715003 | In distribution | |
| 99701755 | Outer Diameter 5.5 mm | In distribution |
| 99701455 | Outer Diameter 5.5 mm | In distribution |
| 99731002 | In distribution | |
| 99781203 | In distribution | |
| 01714001 | In distribution | |
| 99701495 | Outer Diameter 9.5 mm | In distribution |
| 99702000 | In distribution | |
| 99762001 | In distribution | |
| 99731000 | In distribution | |
| 99750003 | In distribution | |
| 99741001 | In distribution | |
| 99701475 | Outer Diameter 7.5 mm | In distribution |
| 99781200 | In distribution | |
| 99701545 | Outer Diameter 4.5 mm | In distribution |
| 99780001 | In distribution | |
| 99701045 | Outer Diameter 4.5 mm | In distribution |
| 99731008 | In distribution | |
| 99782007 | In distribution | |
| 99730000 | In distribution | |
| 99731006 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Clariance, Inc. | 510(k) number | 2019-07-01 | Class III | Use error | Potential for the polyaxial screw to become disassembled during implant. | 4,090 units distributed in the US | 2020-07-09 |
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.