GII
double locking translation connector
13manufacturers in China registered for this device type
94catalogue 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 | Coligne AG, Switzerland |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K032604 |
| Record published | 2016-09-29 |
| 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 |
|---|---|---|
| 036.634 | In distribution | |
| 78.640 | In distribution | |
| 78.650 | In distribution | |
| 781.535 | In distribution | |
| 78.840 | In distribution | |
| 32.735 | In distribution | |
| 78.870 | In distribution | |
| 78.755 | In distribution | |
| 79.735 | In distribution | |
| 036.542 | In distribution | |
| 781.745 | In distribution | |
| P52.645 NC | In distribution | |
| 78.550 | In distribution | |
| P60.42.040 | In distribution | |
| 79.535 | In distribution | |
| 781.555 | In distribution | |
| 32.540 NC | In distribution | |
| 32.845 NC | In distribution | |
| 32.755 | In distribution | |
| 62.400 | In distribution | |
| 79.640 | In distribution | |
| 32.945 NC | In distribution | |
| 79.545 | In distribution | |
| 62.270 | In distribution | |
| 78.540 | In distribution | |
| P60.42.010 | In distribution | |
| 781.645 | In distribution | |
| 43.014 | In distribution | |
| 32.745 | In distribution | |
| 32.840 | In distribution | |
| 78.002 | In distribution | |
| 78.735 | In distribution | |
| 32.540 | In distribution | |
| 62.150 | In distribution | |
| 43.011 | In distribution | |
| 43.031 | In distribution | |
| 79.650 | In distribution | |
| 32.640 | In distribution | |
| 78.630 | In distribution | |
| 32.660 | In distribution | |
| 62.210 | In distribution | |
| 32.435 NC | In distribution | |
| P60.42.012 | In distribution | |
| 036.580 | In distribution | |
| 62.080 | In distribution | |
| 62.015 | In distribution | |
| 781.545 | In distribution | |
| 32.945 | In distribution | |
| 32.630 | In distribution | |
| 32.640 NC | In distribution | |
| 78.530 | In distribution | |
| 78.745 | In distribution | |
| 32.835 NC | In distribution | |
| P60.42.020 | In distribution | |
| 781.655 | In distribution | |
| 32.750 NC | In distribution | |
| P60.42.030 | In distribution | |
| 79.755 | In distribution | |
| P52.635 NC | In distribution | |
| 32.425 NC | In distribution | |
| 32.640 LM | In distribution | |
| 031.015 | In distribution | |
| 32.530 NC | In distribution | |
| P60.42.013 | In distribution | |
| 62.100 | In distribution | |
| 32.730 NC | In distribution | |
| 036.655 | In distribution | |
| 62.120 | In distribution | |
| 43.018 | In distribution | |
| 32.550 NC | In distribution | |
| 32.650 NC | In distribution | |
| 32.845 LM | In distribution | |
| 32.850 | In distribution | |
| 43.022 | In distribution | |
| 036.540 | In distribution | |
| 32.630 NC | In distribution | |
| 79.660 | In distribution | |
| P60.42.015 | In distribution | |
| 62.060 | In distribution | |
| 32.740 NC | In distribution | |
| 78.660 | In distribution | |
| 62.040 | In distribution | |
| 62.360 | In distribution | |
| 32.530 | In distribution | |
| 036.574 | In distribution | |
| 62.320 | In distribution | |
| 79.745 | In distribution | |
| 036.556 | In distribution | |
| 32.650 | In distribution | |
| 32.850 NC | In distribution | |
| 031.003 | In distribution | |
| 78.770 | In distribution | |
| 79.630 | In distribution | |
| 78.850 | 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.