Protex CT
Top-Loading T-Connector for 3.7mm Rod, 26-46mm, Straight
13manufacturers in China registered for this device type
69catalogue 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, Spinal Pedicle Fixation
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K050391 |
| Record published | 2015-11-06 |
| Record revised | 2025-07-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Length 8 to 350 mm; outer diameter 3.5 to 6.5 mm; lumen/inner diameter 3.7 to 6.5 mm; height 5 to 7 mm; angle 100 to 115 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115.501 | In distribution | |
| 115.530 | Length 30 mm | In distribution |
| 115.959 | Length 15 mm | In distribution |
| 115.532 | Outer Diameter 4.5 mm | In distribution |
| 115.350 | Outer Diameter 3.5 mm | In distribution |
| 115.956 | Length 10 mm | In distribution |
| 115.958 | Length 10 mm | In distribution |
| 115.911 | Length 32 mm | In distribution |
| 115.924 | Length 26 mm | In distribution |
| 115.430 | Outer Diameter 4 mm | In distribution |
| 115.342 | Length 42 mm | In distribution |
| 115.344 | Length 44 mm | In distribution |
| 115.318 | Outer Diameter 3.5 mm | In distribution |
| 115.803 | Outer Diameter 3.7 mm | In distribution |
| 115.990 | Length 9 mm | In distribution |
| 115.424 | Length 24 mm | In distribution |
| 115.509 | Height 5 mm | In distribution |
| 115.432 | Length 32 mm | In distribution |
| 115.983 | Length 350 mm | In distribution |
| 115.540 | Outer Diameter 4.5 mm | In distribution |
| 115.514 | Length 14 mm | In distribution |
| 115.234 | Length 34 mm | In distribution |
| 115.440 | Length 40 mm | In distribution |
| 115.340 | Outer Diameter 3.5 mm | In distribution |
| 115.912 | Length 41 mm | In distribution |
| 115.950 | Length 10 mm | In distribution |
| 115.322 | Length 22 mm | In distribution |
| 115.951 | Length 15 mm | In distribution |
| 115.536 | Length 36 mm | In distribution |
| 115.448 | Length 48 mm | In distribution |
| 115.931 | In distribution | |
| 115.434 | Outer Diameter 4 mm | In distribution |
| 115.965 | Lumen/Inner Diameter 6.5 mm | In distribution |
| 115.410 | Outer Diameter 4 mm | In distribution |
| 115.338 | Outer Diameter 3.5 mm | In distribution |
| 115.504 | In distribution | |
| 115.418 | Length 18 mm | In distribution |
| 115.414 | Length 14 mm | In distribution |
| 115.522 | Outer Diameter 4.5 mm | In distribution |
| 115.516 | Outer Diameter 4.5 mm | In distribution |
| 115.000 | In distribution | |
| 115.986 | Length 350 mm | In distribution |
| 115.508 | Height 7 mm | In distribution |
| 115.428 | Outer Diameter 4 mm | In distribution |
| 115.801 | Outer Diameter 3.7 mm | In distribution |
| 115.953 | Angle 100 ° | In distribution |
| 115.500 | In distribution | |
| 115.546 | Length 46 mm | In distribution |
| 115.949 | In distribution | |
| 115.332 | Length 32 mm | In distribution |
| 115.962 | Lumen/Inner Diameter 5 mm | In distribution |
| 115.446 | Outer Diameter 4 mm | In distribution |
| 115.542 | Length 42 mm | In distribution |
| 115.964 | Lumen/Inner Diameter 6 mm | In distribution |
| 115.981 | Outer Diameter 3.7 mm | In distribution |
| 115.236 | Length 36 mm | In distribution |
| 115.308 | Outer Diameter 3.5 mm | In distribution |
| 115.925 | Length 26 mm | In distribution |
| 115.926 | Length 36 mm | In distribution |
| 115.324 | Outer Diameter 3.5 mm | In distribution |
| 115.507 | Height 5 mm | In distribution |
| 115.957 | Length 15 mm | In distribution |
| 115.960 | Lumen/Inner Diameter 3.7 mm | In distribution |
| 115.524 | Length 24 mm | In distribution |
| 115.503 | In distribution | |
| 115.316 | Length 16 mm | In distribution |
| 115.334 | Outer Diameter 3.5 mm | In distribution |
| 115.954 | Angle 115 ° | In distribution |
| 115.985 | Length 350 mm | 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
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.