SpheRx
SpheRx® DBR®II Screw, 6.5x55mm Cann Poly
13manufacturers in China registered for this device type
102catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Nuvasive, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K090981 |
| Record published | 2019-12-04 |
| Record revised | 2026-01-19 (version 8) |
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 |
|---|---|---|
| 7767570 | In distribution | |
| 7756560 | In distribution | |
| 7754535 | In distribution | |
| 7258555 | In distribution | |
| 7376555 | In distribution | |
| 7292030 | In distribution | |
| 4486540 | In distribution | |
| 7756550 | In distribution | |
| 7377530 | In distribution | |
| 7377560 | In distribution | |
| 7772005 | In distribution | |
| 7758555 | In distribution | |
| 7248510 | In distribution | |
| 7783140 | In distribution | |
| 7765555 | In distribution | |
| 7217020 | In distribution | |
| 7757540 | In distribution | |
| 7237300 | In distribution | |
| 7258535 | In distribution | |
| 4485555 | In distribution | |
| 7754525 | In distribution | |
| 7195550 | In distribution | |
| 7258545 | In distribution | |
| 7783500 | In distribution | |
| 4485550 | In distribution | |
| 7378530 | In distribution | |
| 7237250 | In distribution | |
| 7247580 | In distribution | |
| 4485545 | In distribution | |
| 7783025 | In distribution | |
| 7245550 | In distribution | |
| 7754555 | In distribution | |
| 7758530 | In distribution | |
| 7241119 | In distribution | |
| 7756535 | In distribution | |
| 7236200 | In distribution | |
| 7265555 | In distribution | |
| 7243060 | In distribution | |
| 7241300 | In distribution | |
| 7217130 | In distribution | |
| 7196545 | In distribution | |
| 7246535 | In distribution | |
| 7376540 | In distribution | |
| 7241115 | In distribution | |
| 7291100 | In distribution | |
| 7246545 | In distribution | |
| 7768545 | In distribution | |
| 7267540 | In distribution | |
| 7248125 | In distribution | |
| 7237275 | In distribution | |
| 7378540 | In distribution | |
| 4487530 | In distribution | |
| 7782170 | In distribution | |
| 7754530 | In distribution | |
| 7248115 | In distribution | |
| 7291160 | In distribution | |
| 7237525 | In distribution | |
| 7197545 | In distribution | |
| 7248560 | In distribution | |
| 4487550 | In distribution | |
| 7767510 | In distribution | |
| 7377545 | In distribution | |
| 7284550 | In distribution | |
| 7284530 | In distribution | |
| 7267555 | In distribution | |
| 7237675 | In distribution | |
| 7217040 | In distribution | |
| 7248555 | In distribution | |
| 7251528 | In distribution | |
| 7256550 | In distribution | |
| 7375565 | In distribution | |
| 7276535 | In distribution | |
| 7248040 | In distribution | |
| 4486560 | In distribution | |
| 7248110 | In distribution | |
| 7200503 | In distribution | |
| 7217140 | In distribution | |
| 7291080 | In distribution | |
| 7783060 | In distribution | |
| 7766580 | In distribution | |
| 7767575 | In distribution | |
| 7376565 | In distribution | |
| 7195555 | In distribution | |
| 4486550 | In distribution | |
| 7247555 | In distribution | |
| 7248075 | In distribution | |
| 7248500 | In distribution | |
| 7772001 | In distribution | |
| 7276540 | In distribution | |
| 7376530 | In distribution | |
| 7783150 | In distribution | |
| 7291200 | In distribution | |
| 7248065 | In distribution | |
| 7248575 | In distribution | |
| 7246555 | In distribution | |
| 7291060 | In distribution | |
| 7375530 | In distribution | |
| 7243070 | In distribution | |
| 7782230 | In distribution | |
| 7256020 | In distribution | |
| 4487545 | In distribution | |
| 7378555 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062317 | 2006-09-01 |
| K061778 | 2006-07-18 |
| K060225 | 2006-04-12 |
| K033546 | 2004-04-12 |
Recalls Naming This Product
31 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
| Nuvasive, Inc. | 510(k) number | 2009-01-05 | Class II | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. | 240 units total | 2012-11-19 |
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.