SpheRx
SpheRx® DBR®II Screw, 7.5x40mm Cann Poly
13manufacturers in China registered for this device type
96catalogue numbers in this listing
1510(k) clearance
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, Spinal Pedicle Fixation
Record
| Listed by | Nuvasive, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083028 |
| Record published | 2015-10-24 |
| Record revised | 2025-06-11 (version 6) |
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 |
|---|---|---|
| 4484540 | In distribution | |
| 4485530 | In distribution | |
| 7783090 | In distribution | |
| 7246565 | In distribution | |
| 7217150 | In distribution | |
| 7783035 | In distribution | |
| 7247570 | In distribution | |
| 7247575 | In distribution | |
| 7377540 | In distribution | |
| 7758540 | In distribution | |
| 7782500 | In distribution | |
| 7755545 | In distribution | |
| 7256530 | In distribution | |
| 7291055 | In distribution | |
| 7248135 | In distribution | |
| 7256555 | In distribution | |
| 7375540 | In distribution | |
| 7237725 | In distribution | |
| 7783100 | In distribution | |
| 7241121 | In distribution | |
| 7241275 | In distribution | |
| 7256540 | In distribution | |
| 7764555 | In distribution | |
| 7246550 | In distribution | |
| 7237325 | In distribution | |
| 7236175 | In distribution | |
| 7217065 | In distribution | |
| 7375535 | In distribution | |
| 7255535 | In distribution | |
| 7291030 | In distribution | |
| 7257535 | In distribution | |
| 7236250 | In distribution | |
| 7768535 | In distribution | |
| 7247540 | In distribution | |
| 7292060 | In distribution | |
| 4485540 | In distribution | |
| 7254545 | In distribution | |
| 7265550 | In distribution | |
| 4485535 | In distribution | |
| 4484545 | In distribution | |
| 7764540 | In distribution | |
| 7375560 | In distribution | |
| 7292120 | In distribution | |
| 7248540 | In distribution | |
| 7377550 | In distribution | |
| 7248080 | In distribution | |
| 7291095 | In distribution | |
| 7253112 | In distribution | |
| 7254530 | In distribution | |
| 7241550 | In distribution | |
| 7256018 | In distribution | |
| 7241150 | In distribution | |
| 7217075 | In distribution | |
| 7766565 | In distribution | |
| 7757555 | In distribution | |
| 7241075 | In distribution | |
| 7241040 | In distribution | |
| 7249350 | In distribution | |
| 7377555 | In distribution | |
| 7291045 | In distribution | |
| 7195535 | In distribution | |
| 7247565 | In distribution | |
| 7782200 | In distribution | |
| 7248025 | In distribution | |
| 7764560 | In distribution | |
| 7245555 | In distribution | |
| 7217050 | In distribution | |
| 7756530 | In distribution | |
| 7783130 | In distribution | |
| 7754540 | In distribution | |
| 7237600 | In distribution | |
| 7251626 | In distribution | |
| 7755555 | In distribution | |
| 7257550 | In distribution | |
| 7757560 | In distribution | |
| 7764550 | In distribution | |
| 7237500 | In distribution | |
| 7241110 | In distribution | |
| 7254550 | In distribution | |
| 7291025 | In distribution | |
| 7256560 | In distribution | |
| 7217035 | In distribution | |
| 7755540 | In distribution | |
| 7758560 | In distribution | |
| 7237750 | In distribution | |
| 7766560 | In distribution | |
| 7291050 | In distribution | |
| 7196535 | In distribution | |
| 7217030 | In distribution | |
| 7197540 | In distribution | |
| 7241109 | In distribution | |
| 7768585 | In distribution | |
| 7767530 | In distribution | |
| 7256535 | In distribution | |
| 7217080 | In distribution | |
| 7291150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071435 | 2007-08-06 |
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.