PressON™
Locking Distractor, Hinged, 80 mm Arms, Left, 120 mm Rack (CS-0138)
13manufacturers in China registered for this device type
352catalogue 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 | Nexus Spine, L.L.C., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K133287 |
| Record published | 2021-12-17 |
| Record revised | 2025-07-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 12 to 100 mm; width 1.4 to 36 mm |
| Distribution end date | 2026-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 520717 | Width 8.5 mm | In distribution |
| 520840 | Length 30 mm | In distribution |
| 520826 | Width 7.5 mm | In distribution |
| 520718 | Width 8.5 mm | In distribution |
| 520845 | Length 40 mm | In distribution |
| 520851 | Length 52 mm | In distribution |
| 520820 | Width 6 mm | In distribution |
| 520709 | Width 7.5 mm | In distribution |
| 520727 | Width 8.5 mm | In distribution |
| 520860 | Length 72.5 mm | In distribution |
| 520848 | Length 46 mm | In distribution |
| 520857 | Length 65 mm | In distribution |
| 520298S | Length 60 mm | In distribution |
| 520821 | Width 6 mm | In distribution |
| 520819 | Width 6 mm | In distribution |
| 520655 | Length 14 mm | In distribution |
| 520802 | Width 6.5 mm | In distribution |
| 520759 | Width 8.5 mm | In distribution |
| 520306S | Length 80 mm | In distribution |
| 520827 | Width 7.5 mm | In distribution |
| 520830 | Width 8.5 mm | In distribution |
| 520873 | Length 34 mm | In distribution |
| 520702 | Width 6.5 mm | In distribution |
| 520876 | Length 20 mm | In distribution |
| 520870 | Length 28 mm | In distribution |
| 520147S | In distribution | |
| 520305S | In distribution | |
| 520850 | Length 50 mm | In distribution |
| 520610 | Length 20 mm | In distribution |
| 520866 | Length 20 mm | In distribution |
| 520854 | Length 58 mm | In distribution |
| 520878 | Length 24 mm | In distribution |
| 520859 | Length 70 mm | In distribution |
| 520304 | Length 75 mm | In distribution |
| 520804 | Width 6.5 mm | In distribution |
| 520852 | Length 54 mm | In distribution |
| 520656 | Length 16 mm | In distribution |
| 520869 | Length 26 mm | In distribution |
| 520817 | Width 6 mm | In distribution |
| 520832 | Width 8.5 mm | In distribution |
| 520829 | Width 7.5 mm | In distribution |
| 520725 | Width 8.5 mm | In distribution |
| 520798 | Width 5.5 mm | In distribution |
| 520871 | Length 30 mm | In distribution |
| 520872 | Length 32 mm | In distribution |
| 520302S | Length 70 mm | In distribution |
| 520611 | Length 22 mm | In distribution |
| 520858 | Length 67.5 mm | In distribution |
| 520306 | Length 80 mm | In distribution |
| 520823 | Width 7.5 mm | In distribution |
| 520750 | Width 7.5 mm | In distribution |
| 520299 | In distribution | |
| 520617 | Length 34 mm | In distribution |
| 520616 | Length 32 mm | In distribution |
| 520613 | Length 26 mm | In distribution |
| 520301 | In distribution | |
| 520855 | Length 60 mm | In distribution |
| 520881 | Length 30 mm | In distribution |
| 520805 | Width 6.5 mm | In distribution |
| 520614 | Length 28 mm | In distribution |
| 520297S | Length 57 mm | In distribution |
| 520303 | In distribution | |
| 520304S | Length 75 mm | In distribution |
| 520609 | Length 18 mm | In distribution |
| 520824 | Width 7.5 mm | In distribution |
| 520867 | Length 22 mm | In distribution |
| 520838 | Length 26 mm | In distribution |
| 520861 | Length 75 mm | In distribution |
| 520760 | Width 8.5 mm | In distribution |
| 520874 | Length 36 mm | In distribution |
| 520868 | Length 24 mm | In distribution |
| 520864 | In distribution | |
| 520818 | Width 6 mm | In distribution |
| 520300 | Length 65 mm | In distribution |
| 520842 | Length 34 mm | In distribution |
| 520883 | Length 34 mm | In distribution |
| 520298 | Length 60 mm | In distribution |
| 520877 | Length 22 mm | In distribution |
| 520618 | Width 36 mm | In distribution |
| 520722 | Width 8.5 mm | In distribution |
| 520301S | In distribution | |
| 520762 | Width 8.5 mm | In distribution |
| 520800 | Width 5.5 mm | In distribution |
| 520847 | Length 44 mm | In distribution |
| 520305 | In distribution | |
| 520758 | Width 8.5 mm | In distribution |
| 520839 | Length 28 mm | In distribution |
| 520761 | Width 8.5 mm | In distribution |
| 520799 | Width 5.5 mm | In distribution |
| 520615 | Length 30 mm | In distribution |
| 520856 | Length 62.5 mm | In distribution |
| 520146S | In distribution | |
| 520831 | Width 8.5 mm | In distribution |
| 520884 | Length 36 mm | In distribution |
| 520801 | Width 5.5 mm | In distribution |
| 520849 | Length 48 mm | In distribution |
| 520879 | Length 26 mm | In distribution |
| 520299S | In distribution | |
| 520724 | Width 8.5 mm | In distribution |
| 520822 | Width 7.5 mm | In distribution |
| 520875 | Length 18 mm | In distribution |
| 520882 | Length 32 mm | In distribution |
| 520726 | Width 8.5 mm | In distribution |
| 520843 | Length 36 mm | In distribution |
| 520846 | Length 42 mm | In distribution |
| 820360 | In distribution | |
| 520300S | Length 65 mm | In distribution |
| 520654 | Length 12 mm | In distribution |
| 520862 | Length 77.5 mm | In distribution |
| 520797 | Width 5.5 mm | In distribution |
| 520728 | Width 8.5 mm | In distribution |
| 520865 | Length 18 mm | In distribution |
| 520825 | Width 7.5 mm | In distribution |
| 520806 | Width 6.5 mm | In distribution |
| 520863 | Length 80 mm | In distribution |
| 520880 | Length 28 mm | In distribution |
| 520303S | In distribution | |
| 520612 | Length 24 mm | In distribution |
| 520841 | Length 32 mm | In distribution |
| 820322.04 | Width 15 mm | In distribution |
| 520837 | Length 24 mm | In distribution |
| 520723 | Width 8.5 mm | In distribution |
| 520833 | Width 8.5 mm | In distribution |
| 520297 | Length 57 mm | In distribution |
| 520853 | Length 56 mm | In distribution |
| 520828 | Width 7.5 mm | In distribution |
| 520302 | Length 70 mm | In distribution |
| 520636 | Length 58 mm | Withdrawn |
| 820319.17 | Length 50 mm | Withdrawn |
| 520220 | Width 5.5 mm | Withdrawn |
| 820319 | Withdrawn | |
| 520480 | Length 36 mm | Withdrawn |
| 520736 | Width 6.5 mm | Withdrawn |
| 520411 | Length 61 mm | Withdrawn |
| 520216 | Width 5.5 mm | Withdrawn |
| 820241o | Withdrawn | |
| 520241 | Length 45 mm | Withdrawn |
| 520290 | Length 36 mm | Withdrawn |
| 520288 | Length 32 mm | Withdrawn |
| 520815 | Width 6.5 mm | Withdrawn |
| 820319.03 | Length 40 mm | Withdrawn |
| 520740 | Width 6.5 mm | Withdrawn |
| 520608 | Length 36 mm | Withdrawn |
| 820319.08 | Withdrawn | |
| 520652 | Length 14 mm | Withdrawn |
| 520729 | Width 5.5 mm | Withdrawn |
| 520754 | Width 8.5 mm | Withdrawn |
| 520404 | Length 33 mm | Withdrawn |
| 520744 | Width 7.5 mm | Withdrawn |
| 820319.09 | Withdrawn | |
| 820322.01 | Width 15 mm | Withdrawn |
| 520626 | Length 38 mm | Withdrawn |
| 520285 | Length 26 mm | Withdrawn |
| 520640 | Length 67.5 mm | Withdrawn |
| 520224 | Width 6.5 mm | Withdrawn |
| 820319.19 | Length 70 mm | Withdrawn |
| 820321.02 | Withdrawn | |
| 520406 | Length 41 mm | Withdrawn |
| 820319.02 | Length 35 mm | Withdrawn |
| 520602 | Length 24 mm | Withdrawn |
| 520807 | Width 5.5 mm | Withdrawn |
| 520775 | Width 4.5 mm | Withdrawn |
| 520628 | Length 42 mm | Withdrawn |
| 820319.15 | Withdrawn | |
| 520742 | Width 6.5 mm | Withdrawn |
| 520147 | Withdrawn | |
| 520753 | Width 8.5 mm | Withdrawn |
| 820343 | Withdrawn | |
| 520231 | Width 7.5 mm | Withdrawn |
| 520782 | Width 5 mm | Withdrawn |
| 820319.14 | Withdrawn | |
| 520627 | Length 40 mm | Withdrawn |
| 520605 | Length 30 mm | Withdrawn |
| 520469 | Length 14 mm | Withdrawn |
| 820324 | Withdrawn | |
| 820319.21 | Length 90 mm | Withdrawn |
| 520240 | Length 40 mm | Withdrawn |
| 520774 | Width 4.5 mm | Withdrawn |
| 520645 | Length 80 mm | Withdrawn |
| 520363 | Width 4.5 mm | Withdrawn |
| 520218 | Width 5.5 mm | Withdrawn |
| 520781 | Width 5 mm | Withdrawn |
| 820319.13 | Withdrawn | |
| 520621 | Length 28 mm | Withdrawn |
| 520474 | Length 24 mm | Withdrawn |
| 520811 | Width 5.5 mm | Withdrawn |
| 520239 | Length 35 mm | Withdrawn |
| 520278 | Length 12 mm | Withdrawn |
| 520281 | Length 18 mm | Withdrawn |
| 520629 | Length 44 mm | Withdrawn |
| 520232 | Width 7.5 mm | Withdrawn |
| 820240o | Withdrawn | |
| 520814 | Width 6.5 mm | Withdrawn |
| 820322.02 | Width 15 mm | Withdrawn |
| 520217 | Width 5.5 mm | Withdrawn |
| 520604 | Length 28 mm | Withdrawn |
| 820336PH | Withdrawn | |
| 520623 | Length 32 mm | Withdrawn |
| 520410 | Length 57 mm | Withdrawn |
| 520296 | Length 54 mm | Withdrawn |
| 520622 | Length 30 mm | Withdrawn |
| 520739 | Width 6.5 mm | Withdrawn |
| 520292 | Length 42 mm | Withdrawn |
| 820319.18 | Length 60 mm | Withdrawn |
| 520600 | Length 20 mm | Withdrawn |
| 520625 | Length 36 mm | Withdrawn |
| 520403 | Length 29 mm | Withdrawn |
| 520362 | Width 4.5 mm | Withdrawn |
| 520146 | Withdrawn | |
| 520219 | Width 5.5 mm | Withdrawn |
| 820327 | Withdrawn | |
| 820319.11 | Withdrawn | |
| 520619 | Length 24 mm | Withdrawn |
| 520638 | Length 62.5 mm | Withdrawn |
| 820322.05 | Width 25 mm | Withdrawn |
| 520641 | Length 70 mm | Withdrawn |
| 520751 | Width 8.5 mm | Withdrawn |
| 820319.04 | Length 45 mm | Withdrawn |
| 520370 | Width 5 mm | Withdrawn |
| 820319.22 | Length 100 mm | Withdrawn |
| 520635 | Length 56 mm | Withdrawn |
| 820322.06 | Width 25 mm | Withdrawn |
| 520599 | Length 18 mm | Withdrawn |
| 520810 | Width 5.5 mm | Withdrawn |
| 520776 | Width 4.5 mm | Withdrawn |
| 520369 | Width 5 mm | Withdrawn |
| 520372 | Width 5 mm | Withdrawn |
| 520367 | Width 4.5 mm | Withdrawn |
| 520366 | Width 4.5 mm | Withdrawn |
| 820328 | Withdrawn | |
| 520223 | Width 6.5 mm | Withdrawn |
| 520752 | Width 8.5 mm | Withdrawn |
| 520472 | Length 20 mm | Withdrawn |
| 520730 | Width 5.5 mm | Withdrawn |
| 820338BH | Withdrawn | |
| 820319.24 | Withdrawn | |
| 520368 | Width 5 mm | Withdrawn |
| 520407 | Length 45 mm | Withdrawn |
| 520731 | Width 5.5 mm | Withdrawn |
| 820352 | Withdrawn | |
| 520365 | Width 4.5 mm | Withdrawn |
| 520777 | Width 4.5 mm | Withdrawn |
| 820353 | Withdrawn | |
| 520280 | Length 16 mm | Withdrawn |
| 520215 | Width 5.5 mm | Withdrawn |
| 520748 | Width 7.5 mm | Withdrawn |
| 520228 | Width 6.5 mm | Withdrawn |
| 820338PH | Withdrawn | |
| 520732 | Width 5.5 mm | Withdrawn |
| 520479 | Length 34 mm | Withdrawn |
Showing 250 of 300 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.