GII
transverse connector set screw
11manufacturers in China registered for this device type
88catalogue numbers in this listing
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 | Coligne AG, Switzerland |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Manufacturer |
| 510(k) | K083567 |
| Record published | 2016-09-28 |
| Record revised | 2025-07-02 (version 4) |
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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 78.845 | In distribution | |
| 32.655 NC | In distribution | |
| P60.42.035 | In distribution | |
| 32.545 | In distribution | |
| 781.740 | In distribution | |
| 78.740 | In distribution | |
| 62.090 | In distribution | |
| 43.015 | In distribution | |
| 32.645 | In distribution | |
| 32.730 | In distribution | |
| 32.655 | In distribution | |
| 79.730 | In distribution | |
| 32.535 | In distribution | |
| 79.530 | In distribution | |
| 62.130 | In distribution | |
| 62.240 | In distribution | |
| 79.750 | In distribution | |
| 43.012 | In distribution | |
| 32.760 | In distribution | |
| 62.340 | In distribution | |
| 32.950 NC | In distribution | |
| 32.645 NC | In distribution | |
| 32.860 | In distribution | |
| 62.050 | In distribution | |
| 32.740 | In distribution | |
| 78.835 | In distribution | |
| 79.740 | In distribution | |
| 32.950 | In distribution | |
| 43.019 | In distribution | |
| 781.540 | In distribution | |
| 78.730 | In distribution | |
| 32.750 | In distribution | |
| 79.760 | In distribution | |
| 78.645 | In distribution | |
| 78.655 | In distribution | |
| 781.650 | In distribution | |
| 32.535 NC | In distribution | |
| 78.555 | In distribution | |
| 32.635 NC | In distribution | |
| 62.600 | In distribution | |
| 32.635 | In distribution | |
| 62.300 | In distribution | |
| 32.420 NC | In distribution | |
| 62.180 | In distribution | |
| 78.545 | In distribution | |
| 78.535 | In distribution | |
| 32.755 NC | In distribution | |
| P52.640 NC | In distribution | |
| 79.655 | In distribution | |
| 32.840 NC | In distribution | |
| 781.550 | In distribution | |
| 43.010 | In distribution | |
| 62.070 | In distribution | |
| 036.575 | In distribution | |
| 78.635 | In distribution | |
| 32.740 LM | In distribution | |
| 79.550 | In distribution | |
| 036.570 | In distribution | |
| 32.430 NC | In distribution | |
| 79.540 | In distribution | |
| 32.845 | In distribution | |
| 78.880 | In distribution | |
| 036.013 | In distribution | |
| 32.940 | In distribution | |
| 32.735 NC | In distribution | |
| 62.016 | In distribution | |
| 32.940 NC | In distribution | |
| P52.745 NC | In distribution | |
| 036.005 | In distribution | |
| 32.440 NC | In distribution | |
| 78.760 | In distribution | |
| 32.545 NC | In distribution | |
| 62.014 | In distribution | |
| 43.030 | In distribution | |
| 78.750 | In distribution | |
| 79.635 | In distribution | |
| 32.555 NC | In distribution | |
| 036.541 | In distribution | |
| 79.645 | In distribution | |
| 20.015 | In distribution | |
| P60.42.025 | In distribution | |
| P60.42.115 | In distribution | |
| 62.380 | In distribution | |
| 781.640 | In distribution | |
| 32.745 NC | In distribution | |
| 62.110 | In distribution | |
| 781.750 | In distribution | |
| 78.860 | 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
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.