Sfs;sfs Le;sfs Scoli
8.5MM X 40MM Multi-Axial Screw Self Tapping
13manufacturers in China registered for this device type
286catalogue 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 | Orthofix US LLC, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K080407 |
| Record published | 2019-03-19 |
| Record revised | 2026-02-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 59-3565 | In distribution | |
| 59-4465 | In distribution | |
| 58-3840 | In distribution | |
| 58-3430 | In distribution | |
| 56-3760 | In distribution | |
| 56-3655 | In distribution | |
| 58-3870 | In distribution | |
| 59-4845 | In distribution | |
| 56-3460 | In distribution | |
| 59-3745 | In distribution | |
| 56-3665 | In distribution | |
| 59-3850 | In distribution | |
| 59-4740 | In distribution | |
| 59-4630 | In distribution | |
| 56-3560 | In distribution | |
| 59-3730 | In distribution | |
| 58-3770 | In distribution | |
| 59-3660 | In distribution | |
| 56-3425 | In distribution | |
| 58-3465 | In distribution | |
| 59-4665 | In distribution | |
| 58-3760 | In distribution | |
| 59-3865 | In distribution | |
| 56-3470 | In distribution | |
| 59-4635 | In distribution | |
| 59-4545 | In distribution | |
| 59-4640 | In distribution | |
| 55-4740 | In distribution | |
| 55-4445 | In distribution | |
| 59-3560 | In distribution | |
| 59-4880 | In distribution | |
| 59-4855 | In distribution | |
| 58-3570 | In distribution | |
| 55-4670 | In distribution | |
| 58-3865 | In distribution | |
| 59-4660 | In distribution | |
| 59-3540 | In distribution | |
| 59-4825 | In distribution | |
| 59-4870 | In distribution | |
| 55-4430 | In distribution | |
| 58-3765 | In distribution | |
| 58-3560 | In distribution | |
| 55-4425 | In distribution | |
| 58-3730 | In distribution | |
| 58-3880 | In distribution | |
| 55-4835 | In distribution | |
| 56-3565 | In distribution | |
| 59-4570 | In distribution | |
| 55-4725 | In distribution | |
| 55-4765 | In distribution | |
| 59-3770 | In distribution | |
| 59-4755 | In distribution | |
| 56-3450 | In distribution | |
| 59-4455 | In distribution | |
| 56-3835 | In distribution | |
| 56-3625 | In distribution | |
| 58-3850 | In distribution | |
| 56-3645 | In distribution | |
| 55-4630 | In distribution | |
| 59-4865 | In distribution | |
| 55-4565 | In distribution | |
| 56-2001 | In distribution | |
| 59-4775 | In distribution | |
| 56-3850 | In distribution | |
| 56-3445 | In distribution | |
| 56-3775 | In distribution | |
| 55-4775 | In distribution | |
| 59-4725 | In distribution | |
| 56-3825 | In distribution | |
| 59-3545 | In distribution | |
| 59-4655 | In distribution | |
| 56-3525 | In distribution | |
| 56-3540 | In distribution | |
| 59-3845 | In distribution | |
| 59-3665 | In distribution | |
| 59-4875 | In distribution | |
| 59-3870 | In distribution | |
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| 55-4880 | In distribution | |
| 59-3760 | In distribution | |
| 55-4855 | In distribution | |
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| 59-3855 | In distribution | |
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| 59-3755 | In distribution | |
| 59-3555 | In distribution | |
| 56-3765 | In distribution | |
| 58-3775 | In distribution | |
| 59-4730 | In distribution | |
| 58-3470 | In distribution | |
| 59-4670 | In distribution | |
| 55-4465 | In distribution | |
| 59-4830 | In distribution | |
| 58-3450 | In distribution | |
| 59-4565 | In distribution | |
| 56-3640 | In distribution | |
| 58-3860 | In distribution | |
| 59-3430 | In distribution | |
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| 59-4750 | In distribution | |
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| 59-4525 | In distribution | |
| 59-3825 | In distribution | |
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| 56-3840 | In distribution | |
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| 55-4645 | In distribution | |
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| 55-4755 | In distribution | |
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| 59-4735 | In distribution | |
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| 58-3645 | In distribution | |
| 59-3530 | In distribution | |
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| 55-4555 | In distribution | |
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| 58-3655 | In distribution | |
| 59-3780 | In distribution | |
| 59-4680 | In distribution | |
| 56-3630 | In distribution | |
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| 58-3640 | In distribution | |
| 56-3860 | In distribution | |
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| 56-3725 | In distribution | |
| 59-3455 | In distribution | |
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| 56-3465 | In distribution | |
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| 59-4445 | In distribution | |
| 59-4675 | In distribution | |
| 55-4455 | In distribution | |
| 59-3625 | In distribution | |
| 58-3525 | In distribution | |
| 55-4625 | In distribution | |
| 59-4430 | In distribution | |
| 59-3680 | In distribution | |
| 59-3435 | In distribution | |
| 59-3450 | In distribution | |
| 58-3445 | In distribution | |
| 58-3425 | In distribution | |
| 59-3525 | In distribution | |
| 58-3540 | In distribution | |
| 56-3865 | In distribution | |
| 59-3675 | In distribution | |
| 58-3565 | In distribution | |
| 55-4850 | In distribution | |
| 56-3455 | In distribution |
Showing 250 of 286 catalogue numbers.
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.