P.l.u.s.®
ST Pre-bent rods, right side (iliac)
13manufacturers in China registered for this device type
190catalogue 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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Spinevision SAS, France |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K021507 |
| Record published | 2015-10-21 |
| Record revised | 2025-01-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| U1 – R613T | Diameter: 6.0 Milliimeters Length: 130 Milliimeters | In distribution |
| U1-T659 | Length: 59 Milliimeters | In distribution |
| U1 – R625HT | Diameter: 6.0 Milliimeters Length: 250 Milliimeters | In distribution |
| U1-M860T | Diameter: 8.5 Milliimeters Length: 60 Milliimeters | In distribution |
| U1-H31R | Length: 13,2 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R637T | Diameter: 6.0 Milliimeters Length: 370 Milliimeters | In distribution |
| U1-S520 | Diameter: 5.5 Milliimeters Length: 20 Milliimeters | In distribution |
| U1 – R616H | Diameter: 6.0 Milliimeters Length: 160 Milliimeters | In distribution |
| U1-S530T | Diameter: 5.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1 – R633 | Diameter: 6.0 Milliimeters Length: 330 Milliimeters | In distribution |
| U1-F870T | Diameter: 8.5 Milliimeters Length: 70 Milliimeters | In distribution |
| U1 – R656H | Diameter: 6.0 Milliimeters Length: 560 Milliimeters | In distribution |
| U1 – R645HT | Diameter: 6.0 Milliimeters Length: 450 Milliimeters | In distribution |
| U1 – R630HS | Diameter: 6.0 Milliimeters Length: 300 Milliimeters | In distribution |
| U1-M840T | Diameter: 8.5 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R627H | Diameter: 6.0 Milliimeters Length: 270 Milliimeters | In distribution |
| U1-S740 | Diameter: 7.5 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R654H | Diameter: 6.0 Milliimeters Length: 540 Milliimeters | In distribution |
| U1 – R643HT | Diameter: 6.0 Milliimeters Length: 430 Milliimeters | In distribution |
| U1-M725 | Diameter: 7.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1 – R639T | Diameter: 6.0 Milliimeters Length: 390 Milliimeters | In distribution |
| U1 – R612HT | Diameter: 6.0 Milliimeters Length: 120 Milliimeters | In distribution |
| U1 – R646HT | Diameter: 6.0 Milliimeters Length: 460 Milliimeters | In distribution |
| U1-S745T | Diameter: 7.5 Milliimeters Length: 45 Milliimeters | In distribution |
| U1 – R654HS | Diameter: 6.0 Milliimeters Length: 540 Milliimeters | In distribution |
| U1-T626 | Length: 26 Milliimeters | In distribution |
| U1-L302T | Length: 31,5 Milliimeters Height: 11 Milliimeters | In distribution |
| U1 – R650 | Diameter: 6.0 Milliimeters Length: 500 Milliimeters | In distribution |
| U1-H20R | Length: 14,7 Milliimeters, Width: 10,6 Milliimeters, Height: 21,3 Milliimeters | In distribution |
| U1 – R612H | Diameter: 6.0 Milliimeters Length: 120 Milliimeters | In distribution |
| U1 – R621HS | Diameter: 6.0 Milliimeters Length: 210 Milliimeters | In distribution |
| U1-T614 | Length: 87,5 Milliimeters Diameter: 4 Milliimeters | In distribution |
| U1 – R638 | Diameter: 6.0 Milliimeters Length: 380 Milliimeters | In distribution |
| U1-S750 | Diameter: 7.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1-H201T | Length: 14,7 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R647T | Diameter: 6.0 Milliimeters Length: 470 Milliimeters | In distribution |
| U1 – R644H | Diameter: 6.0 Milliimeters Length: 440 Milliimeters | In distribution |
| U1 – R654 | Diameter: 6.0 Milliimeters Length: 540 Milliimeters | In distribution |
| U1 – R632HT | Diameter: 6.0 Milliimeters Length: 320 Milliimeters | In distribution |
| U1-T635 | Length: 35 Milliimeters | In distribution |
| U1-S435 | Diameter: 4.5 Milliimeters Length: 35 Milliimeters | In distribution |
| U1 – R607HT | Diameter: 6.0 Milliimeters Length: 70 Milliimeters | In distribution |
| U1 – R621H | Diameter: 6.0 Milliimeters Length: 210 Milliimeters | In distribution |
| U1 – R659T | Diameter: 6.0 Milliimeters Length: 590 Milliimeters | In distribution |
| U1-S540 | Diameter: 5.5 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R633HS | Diameter: 6.0 Milliimeters Length: 330 Milliimeters | In distribution |
| U1 – R623 | Diameter: 6.0 Milliimeters Length: 230 Milliimeters | In distribution |
| U1 – R609H | Diameter: 6.0 Milliimeters Length: 90 Milliimeters | In distribution |
| U1-S650 | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R615 | Diameter: 6.0 Milliimeters Length: 150 Milliimeters | In distribution |
| U1-H100 | Length: 15 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R655H | Diameter: 6.0 Milliimeters Length: 550 Milliimeters | In distribution |
| U1 – R620T | Diameter: 6.0 Milliimeters Length: 200 Milliimeters | In distribution |
| U1-M870T | Diameter: 8.5 Milliimeters Length: 70 Milliimeters | In distribution |
| U1-S870T | Diameter: 8.5 Milliimeters Length: 70 Milliimeters | In distribution |
| U1 – R653HS | Diameter: 6.0 Milliimeters Length: 530 Milliimeters | In distribution |
| U1 – R643HS | Diameter: 6.0 Milliimeters Length: 430 Milliimeters | In distribution |
| U1 – R637HS | Diameter: 6.0 Milliimeters Length: 370 Milliimeters | In distribution |
| U1-M745T | Diameter: 7.5 Milliimeters Length: 45 Milliimeters | In distribution |
| U1 – R644HS | Diameter: 6.0 Milliimeters Length: 440 Milliimeters | In distribution |
| U1 – R624HS | Diameter: 6.0 Milliimeters Length: 240 Milliimeters | In distribution |
| U1-F750 | Diameter: 7.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1-M645 | Diameter: 6.5 Milliimeters Length: 45 Milliimeters | In distribution |
| U1 – R622HS | Diameter: 6.0 Milliimeters Length: 220 Milliimeters | In distribution |
| U1-M885T | Diameter: 8.5 Milliimeters Length: 85 Milliimeters | In distribution |
| U1 – R624T | Diameter: 6.0 Milliimeters Length: 240 Milliimeters | In distribution |
| U1 – R621HT | Diameter: 6.0 Milliimeters Length: 210 Milliimeters | In distribution |
| U1 – R628 | Diameter: 6.0 Milliimeters Length: 280 Milliimeters | In distribution |
| U1 – R623T | Diameter: 6.0 Milliimeters Length: 230 Milliimeters | In distribution |
| U1-F770 | Diameter: 7.5 Milliimeters Length: 70 Milliimeters | In distribution |
| U1-H300T | Length: 13,2 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R618H | Diameter: 6.0 Milliimeters Length: 180 Milliimeters | In distribution |
| U1 – R655HS | Diameter: 6.0 Milliimeters Length: 550 Milliimeters | In distribution |
| U1 – R642 | Diameter: 6.0 Milliimeters Length: 420 Milliimeters | In distribution |
| U1 – R633H | Diameter: 6.0 Milliimeters Length: 330 Milliimeters | In distribution |
| U1 – R627 | Diameter: 6.0 Milliimeters Length: 270 Milliimeters | In distribution |
| U1-T665 | Length: 65 Milliimeters | In distribution |
| U1 – R651T | Diameter: 6.0 Milliimeters Length: 510 Milliimeters | In distribution |
| U1-IR600R | Diameter: 6 Milliimeters, Length: 100 Milliimeters | In distribution |
| U1 – R648 | Diameter: 6.0 Milliimeters Length: 480 Milliimeters | In distribution |
| U1 – R645 | Diameter: 6.0 Milliimeters Length: 450 Milliimeters | In distribution |
| U1 – R648HT | Diameter: 6.0 Milliimeters Length: 480 Milliimeters | In distribution |
| U1 – R609HS | Diameter: 6.0 Milliimeters Length: 90 Milliimeters | In distribution |
| U1 – R612 | Diameter: 6.0 Milliimeters Length: 120 Milliimeters | In distribution |
| U1-S630 | Diameter: 6.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1 – R635HS | Diameter: 6.0 Milliimeters Length: 350 Milliimeters | In distribution |
| U1 – R625 | Diameter: 6.0 Milliimeters Length: 250 Milliimeters | In distribution |
| U1-T644 | Length: 44 Milliimeters | In distribution |
| U1 – R628HS | Diameter: 6.0 Milliimeters Length: 280 Milliimeters | In distribution |
| U1 – R612T | Diameter: 6.0 Milliimeters Length: 120 Milliimeters | In distribution |
| U1-S420T | Diameter: 4.5 Milliimeters Length: 20 Milliimeters | In distribution |
| U1-S790 | Diameter: 7.5 Milliimeters Length: 90 Milliimeters | In distribution |
| U1-S430T | Diameter: 4.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1-F870 | Diameter: 8.5 Milliimeters Length: 70 Milliimeters | In distribution |
| U1 – R634T | Diameter: 6.0 Milliimeters Length: 340 Milliimeters | In distribution |
| U1 – R651HS | Diameter: 6.0 Milliimeters Length: 510 Milliimeters | In distribution |
| U1-H203T | Length: 14,7 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R660T | Diameter: 6.0 Milliimeters Length: 600 Milliimeters | In distribution |
| U1 – R647 | Diameter: 6.0 Milliimeters Length: 470 Milliimeters | In distribution |
| U1 – R608 | Diameter: 6.0 Milliimeters Length: 80 Milliimeters | In distribution |
| U1-M630T | Diameter: 6.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1 – R639HS | Diameter: 6.0 Milliimeters Length: 390 Milliimeters | In distribution |
| U1 – R610 | Diameter: 6.0 Milliimeters Length: 100 Milliimeters | In distribution |
| U1-M550T | Diameter: 5.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1-M790 | Diameter: 7.5 Milliimeters Length: 90 Milliimeters | In distribution |
| U1-S830 | Diameter: 8.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1 – R626HS | Diameter: 6.0 Milliimeters Length: 260 Milliimeters | In distribution |
| U1-M790T | Diameter: 7.5 Milliimeters Length: 90 Milliimeters | In distribution |
| U1 – R618T | Diameter: 6.0 Milliimeters Length: 180 Milliimeters | In distribution |
| U1 – R655 | Diameter: 6.0 Milliimeters Length: 550 Milliimeters | In distribution |
| U1-M645T | Diameter: 6.5 Milliimeters Length: 45 Milliimeters | In distribution |
| U1 – R606H | Diameter: 6.0 Milliimeters Length: 60 Milliimeters | In distribution |
| U1 – R617T | Diameter: 6.0 Milliimeters Length: 170 Milliimeters | In distribution |
| U1-M725T | Diameter: 7.5 Milliimeters Length: 25 Milliimeters | In distribution |
| U1 – R615HT | Diameter: 6.0 Milliimeters Length: 150 Milliimeters | In distribution |
| U1 – R609T | Diameter: 6.0 Milliimeters Length: 90 Milliimeters | In distribution |
| U1 – R628HT | Diameter: 6.0 Milliimeters Length: 280 Milliimeters | In distribution |
| U1 – R652T | Diameter: 6.0 Milliimeters Length: 520 Milliimeters | In distribution |
| U1 – R639 | Diameter: 6.0 Milliimeters Length: 390 Milliimeters | In distribution |
| U1-T613 | Length: 14,6 Milliimeters, Height : 9 Milliimeters | In distribution |
| U1 – R606 | Diameter: 6.0 Milliimeters Length: 60 Milliimeters | In distribution |
| U1 – R657H | Diameter: 6.0 Milliimeters Length: 570 Milliimeters | In distribution |
| U1-S660T | Diameter: 6.5 Milliimeters Length: 60 Milliimeters | In distribution |
| U1-M740T | Diameter: 7.5 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R641H | Diameter: 6.0 Milliimeters Length: 410 Milliimeters | In distribution |
| U1 – R606T | Diameter: 6.0 Milliimeters Length: 60 Milliimeters | In distribution |
| U1 – R615H | Diameter: 6.0 Milliimeters Length: 150 Milliimeters | In distribution |
| U1 – R645T | Diameter: 6.0 Milliimeters Length: 450 Milliimeters | In distribution |
| U1-M890 | Diameter: 8.5 Milliimeters Length: 90 Milliimeters | In distribution |
| U1 – R638H | Diameter: 6.0 Milliimeters Length: 380 Milliimeters | In distribution |
| U1-S750T | Diameter: 7.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R619HS | Diameter: 6.0 Milliimeters Length: 190 Milliimeters | In distribution |
| U1-H301T | Length: 13,2 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R657HT | Diameter: 6.0 Milliimeters Length: 570 Milliimeters | In distribution |
| U1 – R610HT | Diameter: 6.0 Milliimeters Length: 100 Milliimeters | In distribution |
| U1-S855 | Diameter: 8.5 Milliimeters Length: 55 Milliimeters | In distribution |
| U1-S755 | Diameter: 7.5 Milliimeters Length: 55 Milliimeters | In distribution |
| U1 – R607 | Diameter: 6.0 Milliimeters Length: 70 Milliimeters | In distribution |
| U1 – R660HS | Diameter: 6.0 Milliimeters Length: 600 Milliimeters | In distribution |
| U1-M535 | Diameter: 5.5 Milliimeters Length: 35 Milliimeters | In distribution |
| U1 – R644HT | Diameter: 6.0 Milliimeters Length: 440 Milliimeters | In distribution |
| U1-S890T | Diameter: 8.5 Milliimeters Length: 90 Milliimeters | In distribution |
| U1 – R604HS | Diameter: 6.0 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R626 | Diameter: 6.0 Milliimeters Length: 260 Milliimeters | In distribution |
| U1-M625T | Diameter: 6.5 Milliimeters Length: 25 Milliimeters | In distribution |
| U1-H100T | Length: 14,7 Milliimeters, Width: 10,6 Milliimeters, Height: 21,3 Milliimeters | In distribution |
| U1 – R646HS | Diameter: 6.0 Milliimeters Length: 460 Milliimeters | In distribution |
| U1 – R608HS | Diameter: 6.0 Milliimeters Length: 80 Milliimeters | In distribution |
| U1-M630 | Diameter: 6.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1-H30L | Length: 10 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R604H | Diameter: 6.0 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R631HS | Diameter: 6.0 Milliimeters Length: 310 Milliimeters | In distribution |
| U1 – R621 | Diameter: 6.0 Milliimeters Length: 210 Milliimeters | In distribution |
| U1-M785 | Diameter: 7.5 Milliimeters Length: 85 Milliimeters | In distribution |
| U1-M830 | Diameter: 8.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1-IR600L | Diameter: 6 Milliimeters, Length: 100 Milliimeters | In distribution |
| U1 – R606HT | Diameter: 6.0 Milliimeters Length: 60 Milliimeters | In distribution |
| U1 – R613 | Diameter: 6.0 Milliimeters Length: 130 Milliimeters | In distribution |
| U1 – R629T | Diameter: 6.0 Milliimeters Length: 290 Milliimeters | In distribution |
| U1 – R629H | Diameter: 6.0 Milliimeters Length: 290 Milliimeters | In distribution |
| U1 – R605H | Diameter: 6.0 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R610HS | Diameter: 6.0 Milliimeters Length: 100 Milliimeters | In distribution |
| U1 – R632T | Diameter: 6.0 Milliimeters Length: 320 Milliimeters | In distribution |
| U1 – R652HT | Diameter: 6.0 Milliimeters Length: 520 Milliimeters | In distribution |
| U1-M875T | Diameter: 8.5 Milliimeters Length: 75 Milliimeters | In distribution |
| U1 – R623HT | Diameter: 6.0 Milliimeters Length: 230 Milliimeters | In distribution |
| U1 – R604HT | Diameter: 6.0 Milliimeters Length: 40 Milliimeters | In distribution |
| U1-S535 | Diameter: 5.5 Milliimeters Length: 35 Milliimeters | In distribution |
| U1 – R656HS | Diameter: 6.0 Milliimeters Length: 560 Milliimeters | In distribution |
| U1 – R637HT | Diameter: 6.0 Milliimeters Length: 370 Milliimeters | In distribution |
| U1-H202 | Length: 13,2 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1-S765T | Diameter: 7.5 Milliimeters Length: 65 Milliimeters | In distribution |
| U1 – R655T | Diameter: 6.0 Milliimeters Length: 550 Milliimeters | In distribution |
| U1 – R604 | Diameter: 6.0 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R613H | Diameter: 6.0 Milliimeters Length: 130 Milliimeters | In distribution |
| U1 – R643T | Diameter: 6.0 Milliimeters Length: 430 Milliimeters | In distribution |
| U1 – R635T | Diameter: 6.0 Milliimeters Length: 350 Milliimeters | In distribution |
| U1-S530 | Diameter: 5.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1-S845T | Diameter: 8.5 Milliimeters Length: 45 Milliimeters | In distribution |
| U1 – R605T | Diameter: 6.0 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R648HS | Diameter: 6.0 Milliimeters Length: 480 Milliimeters | In distribution |
| U1-S425 | Diameter: 4.5 Milliimeters Length: 25 Milliimeters | In distribution |
| U1-H31L | Length: 13,2 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R611T | Diameter: 6.0 Milliimeters Length: 110 Milliimeters | In distribution |
| U1-M660 | Diameter: 6.5 Milliimeters Length: 60 Milliimeters | In distribution |
| U1-M765T | Diameter: 7.5 Milliimeters Length: 65 Milliimeters | In distribution |
| U1-M765 | Diameter: 7.5 Milliimeters Length: 65 Milliimeters | In distribution |
| U1 – R645HS | Diameter: 6.0 Milliimeters Length: 450 Milliimeters | In distribution |
| U1 – R653HT | Diameter: 6.0 Milliimeters Length: 530 Milliimeters | In distribution |
| U1 – R651 | Diameter: 6.0 Milliimeters Length: 510 Milliimeters | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal 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.