Protex CT
Top-Loading T-Connector for 3.2mm Rod, 21-33mm, Straight
11manufacturers in China registered for this device type
63catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 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 10 to 500 mm; outer diameter 3.2 to 5.5 mm; lumen/inner diameter 4 to 5.5 mm; angle 130 °; height 7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115.550 | Length 50 mm | In distribution |
| 115.955 | Angle 130 ° | In distribution |
| 115.438 | Length 38 mm | In distribution |
| 115.310 | Length 10 mm | In distribution |
| 115.528 | Outer Diameter 4.5 mm | In distribution |
| 115.228 | Length 28 mm | In distribution |
| 115.416 | Length 16 mm | In distribution |
| 115.952 | In distribution | |
| 115.704 | Length 40 mm | In distribution |
| 115.314 | Outer Diameter 3.5 mm | In distribution |
| 115.232 | Length 32 mm | In distribution |
| 115.506 | Height 7 mm | In distribution |
| 115.444 | Length 44 mm | In distribution |
| 115.538 | Length 38 mm | In distribution |
| 115.702 | Outer Diameter 3.2 mm | In distribution |
| 115.921 | Length 36 mm | In distribution |
| 115.534 | Length 34 mm | In distribution |
| 115.348 | Outer Diameter 3.5 mm | In distribution |
| 115.918 | Length 21 mm | In distribution |
| 115.226 | Length 26 mm | In distribution |
| 115.520 | Outer Diameter 4.5 mm | In distribution |
| 115.923 | Length 21 mm | In distribution |
| 115.420 | Outer Diameter 4 mm | In distribution |
| 115.987 | Outer Diameter 4 mm | In distribution |
| 115.802 | Outer Diameter 3.7 mm | In distribution |
| 115.222 | Length 22 mm | In distribution |
| 115.701 | Length 80 mm | In distribution |
| 115.919 | Length 26 mm | In distribution |
| 115.518 | Length 18 mm | In distribution |
| 115.336 | Length 36 mm | In distribution |
| 115.544 | Length 44 mm | In distribution |
| 115.422 | Length 22 mm | In distribution |
| 115.920 | Length 26 mm | In distribution |
| 115.966 | Lumen/Inner Diameter 4 mm | In distribution |
| 115.979 | Length 240 mm | In distribution |
| 115.426 | Length 26 mm | In distribution |
| 115.961 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 115.512 | Outer Diameter 4.5 mm | In distribution |
| 115.450 | Outer Diameter 4 mm | In distribution |
| 115.526 | Length 26 mm | In distribution |
| 115.412 | Outer Diameter 4 mm | In distribution |
| 115.330 | Length 30 mm | In distribution |
| 115.930 | In distribution | |
| 115.804 | Outer Diameter 3.7 mm | In distribution |
| 115.922 | Length 36 mm | In distribution |
| 115.328 | Outer Diameter 3.5 mm | In distribution |
| 115.984 | Outer Diameter 3.7 mm | In distribution |
| 115.988 | Outer Diameter 3.2 mm | In distribution |
| 115.436 | Length 36 mm | In distribution |
| 115.548 | Length 48 mm | In distribution |
| 115.224 | Length 24 mm | In distribution |
| 115.991 | Length 20 mm | In distribution |
| 115.326 | Outer Diameter 3.5 mm | In distribution |
| 115.346 | Length 46 mm | In distribution |
| 115.963 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 115.510 | Length 10 mm | In distribution |
| 115.312 | Length 12 mm | In distribution |
| 115.320 | Outer Diameter 3.5 mm | In distribution |
| 115.230 | Outer Diameter 3.5 mm | In distribution |
| 115.442 | Length 42 mm | In distribution |
| 115.703 | Outer Diameter 3.2 mm | In distribution |
| 115.989 | Outer Diameter 3.7 mm | In distribution |
| 115.927 | Length 36 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123783 | 2013-03-14 |
| K110963 | 2011-05-05 |
| K102195 | 2011-01-19 |
| K090565 | 2009-06-30 |
| K081906 | 2008-11-14 |
| K052069 | 2005-08-17 |
| K050391 | 2005-07-21 |
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.