UNI-Thread®
Ti 6.5 mm x 28-33 mm Cann. Screw with Cylindrical Post
13manufacturers in China registered for this device type
83catalogue 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) | K052406 |
| Record published | 2015-10-15 |
| 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 |
|---|---|---|
| L2-RCS603LT | Diameter: 6.5 Milliimeters Length: 28Milliimeters | In distribution |
| L2-R606HT | Diameter: 6.0 Milliimeters Length: 60 Milliimeters | In distribution |
| L2-C858T | Diameter: 8.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-C738T | Diameter: 7.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-RC609LT | Diameter: 6.5 Milliimeters Length: 90 Milliimeters | In distribution |
| L2-RC614LT | Diameter: 6.5 Milliimeters Length: 140 Milliimeters | In distribution |
| L2-R606CHT | Diameter: 6.0 Milliimeters Length: 60 Milliimeters | In distribution |
| L2-RC604RT | Diameter: 6.5 Milliimeters Length: 40 Milliimeters | In distribution |
| L2-T613T | Length: 14,6 Milliimeters, Height : 9 Milliimeters | In distribution |
| L2-RC604LT | Diameter: 6.5 Milliimeters Length: 40 Milliimeters | In distribution |
| L2-LSPL175T | Diameter: 7.5 Milliimeters | In distribution |
| L2-RCS608LT | Diameter: 6.5 Milliimeters Length: 80 Milliimeters | In distribution |
| L2-L155T | Diameter: 5.5 Milliimeters | In distribution |
| L2-C543T | Diameter: 5.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-L875T | Diameter: 7.5 Milliimeters | In distribution |
| L2-L175T | Diameter: 7.5 Milliimeters | In distribution |
| L2-CLIS633T | Diameter: 6.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-S538T | Diameter: 5.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-R609HT | Diameter: 6.0 Milliimeters Length: 90 Milliimeters | In distribution |
| L2-S558T | Diameter: 5.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-S738T | Diameter: 7.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-S753T | Diameter: 7.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-R614CHT | Diameter: 6.0 Milliimeters Length: 140 Milliimeters | In distribution |
| L2-CLIS543T | Diameter: 5.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-RC607LT | Diameter: 6.5 Milliimeters Length: 70 Milliimeters | In distribution |
| L2-R607T | Diameter: 6.0 Milliimeters Length: 70 Milliimeters | In distribution |
| L2-CLIS538T | Diameter: 5.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-C833T | Diameter: 8.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-R605T | Diameter: 6.0 Milliimeters Length: 50 Milliimeters | In distribution |
| L2-R625HT | Diameter: 6.0 Milliimeters Length: 250 Milliimeters | In distribution |
| L2-T623T | Length: 23 Milliimeters | In distribution |
| L2-S638T | Diameter: 6.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-S628T | Diameter: 6.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-C853T | Diameter: 8.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-SH543T | Diameter: 5.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-S743T | Diameter: 7.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-CH543T | Diameter: 5.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-C728T | Diameter: 7.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-T665T | Length: 65 Milliimeters | In distribution |
| L2-C828T | Diameter: 8.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-CLIS628T | Diameter: 6.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-T644T | Length: 44 Milliimeters | In distribution |
| L2-C633T | Diameter: 6.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-RC612LT | Diameter: 6.5 Milliimeters Length: 120 Milliimeters | In distribution |
| L2-S640T | Diameter: 6.5 Milliimeters Length: 40 Milliimeters | In distribution |
| L2-S548T | Diameter: 5.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-T632T | Length: 32 Milliimeters | In distribution |
| L2-SH538T | Diameter: 5.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-S650T | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| L2-C733T | Diameter: 7.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-C553T | Diameter: 5.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-L965T | Diameter: 6.5 Milliimeters | In distribution |
| L2-SH528T | Diameter: 5.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-R610T | Diameter: 6.0 Milliimeters Length: 100 Milliimeters | In distribution |
| L2-S728T | Diameter: 7.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-T659T | Length: 59 Milliimeters | In distribution |
| L2-R609CHT | Diameter: 6.0 Milliimeters Length: 90 Milliimeters | In distribution |
| L2-T635T | Length: 35 Milliimeters | In distribution |
| L2-R607CHT | Diameter: 6.0 Milliimeters Length: 70 Milliimeters | In distribution |
| L2-T610T | Length: 14,6 Milliimeters, Height : 9 Milliimeters | In distribution |
| L2-RC606RT | Diameter: 6.5 Milliimeters Length: 60 Milliimeters | In distribution |
| L2-RC603LT | Diameter: 6.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-SH558T | Diameter: 5.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-C753T | Diameter: 7.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-CLIS533T | Diameter: 5.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-C653T | Diameter: 6.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-SH548T | Diameter: 5.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-L665T | Diameter: 6.5 Milliimeters | In distribution |
| L2-RCS607LT | Diameter: 6.5 Milliimeters Length: 70 Milliimeters | In distribution |
| L2-S733T | Diameter: 7.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-R608CHT | Diameter: 6.0 Milliimeters Length: 80 Milliimeters | In distribution |
| L2-RC614RT | Diameter: 6.5 Milliimeters Length: 140 Milliimeters | In distribution |
| L2-R605CHT | Diameter: 6.0 Milliimeters Length: 50 Milliimeters | In distribution |
| L2-C638T | Diameter: 6.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-RC608LT | Diameter: 6.5 Milliimeters Length: 80 Milliimeters | In distribution |
| L2-RCS612LT | Diameter: 6.5 Milliimeters Length: 120 Milliimeters | In distribution |
| L2-L200T | Diameter: 4,2 Milliimeters, Height: 6 Milliimeters | In distribution |
| L2-S658T | Diameter: 6.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-R606T | Diameter: 6.0 Milliimeters Length: 60 Milliimeters | In distribution |
| L2-RC609RT | Diameter: 6.5 Milliimeters Length: 90 Milliimeters | In distribution |
| L2-C743T | Diameter: 7.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-C848T | Diameter: 8.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-C843T | Diameter: 8.5 Milliimeters Length: 43 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.