Protex
SS Top Loading T-Connector for 3.7mm Rod, 26-46mm, Straight
11manufacturers in China registered for this device type
174catalogue 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) | K081906 |
| 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 6 to 500 mm; outer diameter 3.5 to 9 mm; height 5 to 20 mm; angle 20 to 130 °; lumen/inner diameter 3.7 to 5.5 mm; width 6.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 215.340 | Outer Diameter 3.5 mm | In distribution |
| 109.952 | In distribution | |
| 215.801 | Length 80 mm | In distribution |
| 215.635 | Outer Diameter 5 mm | In distribution |
| 102.377 | Length 55 mm | In distribution |
| 215.412 | Outer Diameter 4 mm | In distribution |
| 102.478 | Length 60 mm | In distribution |
| 109.499 | Length 65 mm | In distribution |
| 109.494 | Length 40 mm | In distribution |
| 215.520 | Length 20 mm | In distribution |
| 215.501 | In distribution | |
| 109.374 | Length 40 mm | In distribution |
| 102.052 | Length 75 mm | In distribution |
| 215.226 | Length 26 mm | In distribution |
| 109.453 | Outer Diameter 5 mm | In distribution |
| 215.228 | Length 28 mm | In distribution |
| 215.810 | Outer Diameter 4 mm | In distribution |
| 215.954 | Angle 115 ° | In distribution |
| 215.808 | Length 8 mm | In distribution |
| 215.230 | Outer Diameter 3.5 mm | In distribution |
| 215.222 | Outer Diameter 3.5 mm | In distribution |
| 102.521 | Outer Diameter 6.5 mm | In distribution |
| 215.550 | Length 50 mm | In distribution |
| 109.392 | Outer Diameter 9 mm | In distribution |
| 109.373 | Outer Diameter 7 mm | In distribution |
| 215.906 | Length 6 mm | In distribution |
| 215.802 | Length 120 mm | In distribution |
| 215.912 | Length 12 mm | In distribution |
| 215.326 | Length 26 mm | In distribution |
| 102.484 | Length 40 mm | In distribution |
| 215.803 | Length 240 mm | In distribution |
| 215.422 | Length 22 mm | In distribution |
| 109.477 | Outer Diameter 7 mm | In distribution |
| 215.424 | Length 24 mm | In distribution |
| 102.927 | Height 20 mm | In distribution |
| 109.095 | Length 90 mm | In distribution |
| 109.478 | Outer Diameter 7 mm | In distribution |
| 215.312 | Outer Diameter 3.5 mm | In distribution |
| 215.410 | Outer Diameter 4 mm | In distribution |
| 215.508 | Height 7 mm | In distribution |
| 102.479 | Length 65 mm | In distribution |
| 215.418 | Length 18 mm | In distribution |
| 102.555 | Length 55 mm | In distribution |
| 215.925 | Length 26 mm | In distribution |
| 102.064 | Outer Diameter 9 mm | In distribution |
| 109.455 | Length 45 mm | In distribution |
| 215.308 | Length 8 mm | In distribution |
| 215.236 | Length 36 mm | In distribution |
| 215.990 | Length 9 mm | In distribution |
| 215.350 | Length 50 mm | In distribution |
| 215.414 | Length 14 mm | In distribution |
| 109.356 | Outer Diameter 5 mm | In distribution |
| 215.949 | In distribution | |
| 215.953 | Angle 100 ° | In distribution |
| 102.975 | Length 20 mm | In distribution |
| 215.450 | Length 50 mm | In distribution |
| 215.324 | Length 24 mm | In distribution |
| 102.993 | Length 30 mm | In distribution |
| 109.550 | Outer Diameter 6 mm | In distribution |
| 215.320 | Length 20 mm | In distribution |
| 215.522 | Outer Diameter 4.5 mm | In distribution |
| 102.911 | Length 28 mm | In distribution |
| 102.916 | Length 78 mm | In distribution |
| 215.426 | Outer Diameter 4 mm | In distribution |
| 109.386 | Outer Diameter 8 mm | In distribution |
| 102.560 | Outer Diameter 6.5 mm | In distribution |
| 215.420 | Length 20 mm | In distribution |
| 215.984 | Outer Diameter 5.5 mm | In distribution |
| 109.660 | Outer Diameter 6 mm | In distribution |
| 109.084 | Outer Diameter 8 mm | In distribution |
| 215.440 | Length 40 mm | In distribution |
| 215.959 | Length 15 mm | In distribution |
| 215.535 | Outer Diameter 4.5 mm | In distribution |
| 109.570 | Length 70 mm | In distribution |
| 215.625 | Outer Diameter 5 mm | In distribution |
| 102.469 | Length 65 mm | In distribution |
| 215.430 | Length 30 mm | In distribution |
| 215.950 | Length 10 mm | In distribution |
| 109.487 | Length 55 mm | In distribution |
| 102.379 | Outer Diameter 7 mm | In distribution |
| 102.615 | Length 150 mm | In distribution |
| 109.064 | Length 85 mm | In distribution |
| 102.983 | In distribution | |
| 215.952 | In distribution | |
| 215.510 | Length 10 mm | In distribution |
| 215.910 | Length 10 mm | In distribution |
| 215.330 | Outer Diameter 3.5 mm | In distribution |
| 215.335 | Outer Diameter 3.5 mm | In distribution |
| 215.812 | Length 12 mm | In distribution |
| 215.232 | Length 32 mm | In distribution |
| 215.640 | Outer Diameter 5 mm | In distribution |
| 102.978 | Length 35 mm | In distribution |
| 215.816 | Length 16 mm | In distribution |
| 215.645 | Length 45 mm | In distribution |
| 102.680 | Outer Diameter 6.5 mm | In distribution |
| 215.923 | Length 21 mm | In distribution |
| 215.518 | Outer Diameter 4.5 mm | In distribution |
| 109.399 | Length 65 mm | In distribution |
| 215.804 | Length 40 mm | In distribution |
| 109.670 | Outer Diameter 6 mm | In distribution |
| 109.045 | Length 90 mm | In distribution |
| 109.362 | Length 30 mm | In distribution |
| 109.044 | Length 85 mm | In distribution |
| 109.052 | Length 75 mm | In distribution |
| 215.416 | Length 16 mm | In distribution |
| 215.314 | Length 14 mm | In distribution |
| 215.428 | Length 28 mm | In distribution |
| 215.530 | Length 30 mm | In distribution |
| 109.565 | Outer Diameter 6 mm | In distribution |
| 102.635 | Outer Diameter 6.5 mm | In distribution |
| 215.506 | Height 7 mm | In distribution |
| 215.435 | Length 35 mm | In distribution |
| 102.650 | Outer Diameter 6.5 mm | In distribution |
| 215.328 | Outer Diameter 3.5 mm | In distribution |
| 215.514 | Outer Diameter 4.5 mm | In distribution |
| 215.310 | Length 10 mm | In distribution |
| 215.960 | Lumen/Inner Diameter 3.7 mm | In distribution |
| 215.908 | Length 8 mm | In distribution |
| 109.923 | In distribution | |
| 215.507 | Height 5 mm | In distribution |
| 215.958 | Length 10 mm | In distribution |
| 109.485 | Length 45 mm | In distribution |
| 215.524 | Length 24 mm | In distribution |
| 109.517 | Outer Diameter 6 mm | In distribution |
| 215.234 | Outer Diameter 3.5 mm | In distribution |
| 215.957 | Length 15 mm | In distribution |
| 109.388 | Length 60 mm | In distribution |
| 215.914 | Outer Diameter 4.5 mm | In distribution |
| 102.073 | Length 80 mm | In distribution |
| 109.540 | Outer Diameter 6 mm | In distribution |
| 215.630 | Outer Diameter 5 mm | In distribution |
| 215.540 | Outer Diameter 4.5 mm | In distribution |
| 102.915 | Length 68 mm | In distribution |
| 102.071 | Length 70 mm | In distribution |
| 215.650 | Length 50 mm | In distribution |
| 102.497 | Outer Diameter 9 mm | In distribution |
| 215.512 | Length 12 mm | In distribution |
| 215.814 | Length 14 mm | In distribution |
| 215.526 | Length 26 mm | In distribution |
| 215.916 | Outer Diameter 4.5 mm | In distribution |
| 102.094 | Outer Diameter 9 mm | In distribution |
| 102.464 | Length 40 mm | In distribution |
| 215.545 | Length 45 mm | In distribution |
| 215.318 | Outer Diameter 3.5 mm | In distribution |
| 215.503 | In distribution | |
| 215.806 | Length 6 mm | In distribution |
| 102.054 | Outer Diameter 8 mm | In distribution |
| 102.083 | Length 80 mm | In distribution |
| 215.322 | Length 22 mm | In distribution |
| 215.345 | Outer Diameter 3.5 mm | In distribution |
| 215.963 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 109.355 | Length 45 mm | In distribution |
| 215.316 | Length 16 mm | In distribution |
| 102.976 | Length 25 mm | In distribution |
| 215.528 | Outer Diameter 4.5 mm | In distribution |
| 215.951 | Length 15 mm | In distribution |
| 109.387 | Length 55 mm | In distribution |
| 109.482 | Length 30 mm | In distribution |
| 215.224 | Outer Diameter 3.5 mm | In distribution |
| 102.384 | Length 40 mm | In distribution |
| 102.585 | Outer Diameter 6.5 mm | In distribution |
| 215.956 | Length 10 mm | In distribution |
| 215.509 | Height 5 mm | In distribution |
| 215.955 | Angle 130 ° | In distribution |
| 102.074 | Length 85 mm | In distribution |
| 102.084 | Length 85 mm | In distribution |
| 215.445 | Length 45 mm | In distribution |
| 215.516 | Outer Diameter 4.5 mm | In distribution |
| 215.500 | In distribution | |
| 215.927 | Length 36 mm | In distribution |
| 215.504 | In distribution | |
| 109.685 | Length 85 mm | In distribution |
| 215.991 | Length 20 mm | In distribution |
| 109.675 | Length 75 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.