P.l.u.s.®
TI Small Pedicle Hook With Reduced Groove
13manufacturers in China registered for this device type
140catalogue 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 | Spinevision SAS, France |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K013312 |
| Record published | 2015-10-21 |
| Record revised | 2025-07-14 (version 5) |
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-S635 | Diameter: 6.5 Milliimeters Length: 35 Milliimeters | In distribution |
| U1-M755T | Diameter: 7.5 Milliimeters Length: 55 Milliimeters | In distribution |
| U1 – R641HT | Diameter: 6.0 Milliimeters Length: 410 Milliimeters | In distribution |
| U1 – R659HT | Diameter: 6.0 Milliimeters Length: 590 Milliimeters | In distribution |
| U1-T610 | Length: 14,6 Milliimeters, Height : 9 Milliimeters | In distribution |
| U1-L100T | Length: 11,6 Milliimeters Width: 8,5 Milliimeters | In distribution |
| U1 – R636HT | Diameter: 6.0 Milliimeters Length: 360 Milliimeters | In distribution |
| U1 – R619 | Diameter: 6.0 Milliimeters Length: 190 Milliimeters | In distribution |
| U1-H204T | Length: 14,7 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1-M650 | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R629HT | Diameter: 6.0 Milliimeters Length: 290 Milliimeters | In distribution |
| U1-F750T | Diameter: 7.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1-T647 | Length: 47 Milliimeters | In distribution |
| U1 – R633T | Diameter: 6.0 Milliimeters Length: 330 Milliimeters | In distribution |
| U1-S785 | Diameter: 7.5 Milliimeters Length: 85 Milliimeters | In distribution |
| U1-M845T | Diameter: 8.5 Milliimeters Length: 45 Milliimeters | In distribution |
| U1-F780T | Diameter: 7.5 Milliimeters Length: 80 Milliimeters | In distribution |
| U1-M750T | Diameter: 7.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R608HT | Diameter: 6.0 Milliimeters Length: 80 Milliimeters | In distribution |
| U1-M850 | Diameter: 8.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1-S890 | Diameter: 8.5 Milliimeters Length: 90 Milliimeters | In distribution |
| U1 – R611HT | Diameter: 6.0 Milliimeters Length: 110 Milliimeters | In distribution |
| U1-S550 | Diameter: 5.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1-H30RT | Length: 10 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R624H | Diameter: 6.0 Milliimeters Length: 240 Milliimeters | In distribution |
| U1-M750 | Diameter: 7.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R610T | Diameter: 6.0 Milliimeters Length: 100 Milliimeters | In distribution |
| U1-H102T | Length: 16 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1-S625 | Diameter: 6.5 Milliimeters Length: 25 Milliimeters | In distribution |
| U1-M430T | Diameter: 4.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1 – R642HS | Diameter: 6.0 Milliimeters Length: 420 Milliimeters | In distribution |
| U1 – R639H | Diameter: 6.0 Milliimeters Length: 390 Milliimeters | In distribution |
| U1 – R632HS | Diameter: 6.0 Milliimeters Length: 320 Milliimeters | In distribution |
| U1 – R636H | Diameter: 6.0 Milliimeters Length: 360 Milliimeters | In distribution |
| U1 – R604T | Diameter: 6.0 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R638T | Diameter: 6.0 Milliimeters Length: 380 Milliimeters | In distribution |
| U1-S650T | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R650T | Diameter: 6.0 Milliimeters Length: 500 Milliimeters | In distribution |
| U1-L100 | Length: 11,6 Milliimeters Width: 8,5 Milliimeters | In distribution |
| U1-S785T | Diameter: 7.5 Milliimeters Length: 85 Milliimeters | In distribution |
| U1 – R653 | Diameter: 6.0 Milliimeters Length: 530 Milliimeters | In distribution |
| U1 – R640HS | Diameter: 6.0 Milliimeters Length: 400 Milliimeters | In distribution |
| U1-S635T | Diameter: 6.5 Milliimeters Length: 35 Milliimeters | In distribution |
| U1-M775 | Diameter: 7.5 Milliimeters Length: 75 Milliimeters | In distribution |
| U1-M425T | Diameter: 4.5 Milliimeters Length: 25 Milliimeters | In distribution |
| U1-H200T | Length: 14,7 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1-H204 | Length: 14,7 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1-S625T | Diameter: 6.5 Milliimeters Length: 25 Milliimeters | In distribution |
| U1 – R634HS | Diameter: 6.0 Milliimeters Length: 340 Milliimeters | In distribution |
| U1-S790T | Diameter: 7.5 Milliimeters Length: 90 Milliimeters | In distribution |
| U1 – R625HS | Diameter: 6.0 Milliimeters Length: 250 Milliimeters | In distribution |
| U1 – R614H | Diameter: 6.0 Milliimeters Length: 140 Milliimeters | In distribution |
| U1-L301 | Length: 19,4 Milliimeters, Width: 16,2 Milliimeters, Height: 11 Milliimeters | In distribution |
| U1 – R640H | Diameter: 6.0 Milliimeters Length: 400 Milliimeters | In distribution |
| U1 – R659HS | Diameter: 6.0 Milliimeters Length: 590 Milliimeters | In distribution |
| U1 – R641HS | Diameter: 6.0 Milliimeters Length: 410 Milliimeters | In distribution |
| U1-M635T | Diameter: 6.5 Milliimeters Length: 35 Milliimeters | In distribution |
| U1-F760 | Diameter: 7.5 Milliimeters Length: 60 Milliimeters | In distribution |
| U1 – R646H | Diameter: 6.0 Milliimeters Length: 460 Milliimeters | In distribution |
| U1 – R627HT | Diameter: 6.0 Milliimeters Length: 270 Milliimeters | In distribution |
| U1-H203 | Length: 14,7 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1-F880 | Diameter: 8.5 Milliimeters Length: 80 Milliimeters | In distribution |
| U1 – R648T | Diameter: 6.0 Milliimeters Length: 480 Milliimeters | In distribution |
| U1-S880T | Diameter: 8.5 Milliimeters Length: 80 Milliimeters | In distribution |
| U1 – R658 | Diameter: 6.0 Milliimeters Length: 580 Milliimeters | In distribution |
| U1 – R609 | Diameter: 6.0 Milliimeters Length: 90 Milliimeters | In distribution |
| U1 – R647HT | Diameter: 6.0 Milliimeters Length: 470 Milliimeters | In distribution |
| U1-S545 | Diameter: 5.5 Milliimeters Length: 45 Milliimeters | In distribution |
| U1-S830T | Diameter: 8.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1-H301 | Length: 13,2 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1-T638 | Length: 38 Milliimeters | In distribution |
| U1-M550 | Diameter: 5.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R629 | Diameter: 6.0 Milliimeters Length: 290 Milliimeters | In distribution |
| U1-M850T | Diameter: 8.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R646 | Diameter: 6.0 Milliimeters Length: 460 Milliimeters | In distribution |
| U1 – R641 | Diameter: 6.0 Milliimeters Length: 410 Milliimeters | In distribution |
| U1 – R630 | Diameter: 6.0 Milliimeters Length: 300 Milliimeters | In distribution |
| U1-T620 | Length: 20 Milliimeters | In distribution |
| U1 – R656T | Diameter: 6.0 Milliimeters Length: 560 Milliimeters | In distribution |
| U1 – R617 | Diameter: 6.0 Milliimeters Length: 170 Milliimeters | In distribution |
| U1 – R657T | Diameter: 6.0 Milliimeters Length: 570 Milliimeters | In distribution |
| U1 – R614HS | Diameter: 6.0 Milliimeters Length: 140 Milliimeters | In distribution |
| U1-T632 | Length: 32 Milliimeters | In distribution |
| U1-M420 | Diameter: 4.5 Milliimeters Length: 20 Milliimeters | In distribution |
| U1-S875 | Diameter: 8.5 Milliimeters Length: 75 Milliimeters | In distribution |
| U1 – R657 | Diameter: 6.0 Milliimeters Length: 570 Milliimeters | In distribution |
| U1 – R640HT | Diameter: 6.0 Milliimeters Length: 400 Milliimeters | In distribution |
| U1 – R659 | Diameter: 6.0 Milliimeters Length: 590 Milliimeters | In distribution |
| U1-M430 | Diameter: 4.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1 – R647HS | Diameter: 6.0 Milliimeters Length: 470 Milliimeters | In distribution |
| U1-S850T | Diameter: 8.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1-S860 | Diameter: 8.5 Milliimeters Length: 60 Milliimeters | In distribution |
| U1 – R622 | Diameter: 6.0 Milliimeters Length: 220 Milliimeters | In distribution |
| U1 – R611 | Diameter: 6.0 Milliimeters Length: 110 Milliimeters | In distribution |
| U1 – R650HT | Diameter: 6.0 Milliimeters Length: 500 Milliimeters | In distribution |
| U1-S430 | Diameter: 4.5 Milliimeters Length: 30 Milliimeters | In distribution |
| U1 – R634HT | Diameter: 6.0 Milliimeters Length: 340 Milliimeters | In distribution |
| U1 – R660 | Diameter: 6.0 Milliimeters Length: 600 Milliimeters | In distribution |
| U1 – R610H | Diameter: 6.0 Milliimeters Length: 100 Milliimeters | In distribution |
| U1 – R655HT | Diameter: 6.0 Milliimeters Length: 550 Milliimeters | In distribution |
| U1 – R631T | Diameter: 6.0 Milliimeters Length: 310 Milliimeters | In distribution |
| U1 – R628T | Diameter: 6.0 Milliimeters Length: 280 Milliimeters | In distribution |
| U1-M650T | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1-H30R | Length: 10 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1-M780T | Diameter: 7.5 Milliimeters Length: 80 Milliimeters | In distribution |
| U1-S525T | Diameter: 5.5 Milliimeters Length: 25 Milliimeters | In distribution |
| U1 – R651H | Diameter: 6.0 Milliimeters Length: 510 Milliimeters | In distribution |
| U1-S765 | Diameter: 7.5 Milliimeters Length: 65 Milliimeters | In distribution |
| U1 – R631H | Diameter: 6.0 Milliimeters Length: 310 Milliimeters | In distribution |
| U1 – R635 | Diameter: 6.0 Milliimeters Length: 350 Milliimeters | In distribution |
| U1-L302 | Length: 31,5 Milliimeters Height: 11 Milliimeters | In distribution |
| U1-S545T | Diameter: 5.5 Milliimeters Length: 45 Milliimeters | In distribution |
| U1-S640 | Diameter: 6.5 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R650H | Diameter: 6.0 Milliimeters Length: 500 Milliimeters | In distribution |
| U1 – R637H | Diameter: 6.0 Milliimeters Length: 370 Milliimeters | In distribution |
| U1-S735 | Diameter: 7.5 Milliimeters Length: 35 Milliimeters | In distribution |
| U1 – R617HT | Diameter: 6.0 Milliimeters Length: 170 Milliimeters | In distribution |
| U1-S535T | Diameter: 5.5 Milliimeters Length: 35 Milliimeters | In distribution |
| U1 – R616HT | Diameter: 6.0 Milliimeters Length: 160 Milliimeters | In distribution |
| U1 – R620 | Diameter: 6.0 Milliimeters Length: 200 Milliimeters | In distribution |
| U1 – R627HS | Diameter: 6.0 Milliimeters Length: 270 Milliimeters | In distribution |
| U1 – R630HT | Diameter: 6.0 Milliimeters Length: 300 Milliimeters | In distribution |
| U1-S655T | Diameter: 6.5 Milliimeters Length: 55 Milliimeters | In distribution |
| U1 – R656HT | Diameter: 6.0 Milliimeters Length: 560 Milliimeters | In distribution |
| U1-S645T | Diameter: 6.5 Milliimeters Length: 45 Milliimeters | In distribution |
| U1-F780 | Diameter: 7.5 Milliimeters Length: 80 Milliimeters | In distribution |
| U1 – R644T | Diameter: 6.0 Milliimeters Length: 440 Milliimeters | In distribution |
| U1-H31RT | Length: 13,2 Milliimeters, Width: 10,6 Milliimeters | In distribution |
| U1 – R631HT | Diameter: 6.0 Milliimeters Length: 310 Milliimeters | In distribution |
| U1 – R640T | Diameter: 6.0 Milliimeters Length: 400 Milliimeters | In distribution |
| U1 – R657HS | Diameter: 6.0 Milliimeters Length: 570 Milliimeters | In distribution |
| U1-M440T | Diameter: 4.5 Milliimeters Length: 40 Milliimeters | In distribution |
| U1 – R620HS | Diameter: 6.0 Milliimeters Length: 200 Milliimeters | In distribution |
| U1 – R651HT | Diameter: 6.0 Milliimeters Length: 510 Milliimeters | In distribution |
| U1 – R609HT | Diameter: 6.0 Milliimeters Length: 90 Milliimeters | In distribution |
| U1-S770 | Diameter: 7.5 Milliimeters Length: 70 Milliimeters | In distribution |
| U1-S850 | Diameter: 8.5 Milliimeters Length: 50 Milliimeters | In distribution |
| U1 – R607T | Diameter: 6.0 Milliimeters Length: 70 Milliimeters | In distribution |
| U1 – R636T | Diameter: 6.0 Milliimeters Length: 360 Milliimeters | In distribution |
| U1 – R642H | Diameter: 6.0 Milliimeters Length: 420 Milliimeters | 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.