UNI-Thread®
Ti 6.5 mm x 38-43 mm Cann. Screw with Cylindrical Post
13manufacturers in China registered for this device type
103catalogue 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) | K042640 |
| 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 |
| Sizes | Length 115 to 135 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L2-CLIS643T | Diameter: 6.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-R608HT | Diameter: 6.0 Milliimeters Length: 80 Milliimeters | In distribution |
| L2-RCS604LT | Diameter: 6.5 Milliimeters Length: 40 Milliimeters | In distribution |
| L2-CLIS638T | Diameter: 6.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-RCS606LT | Diameter: 6.5 Milliimeters Length: 60 Milliimeters | In distribution |
| L2-CH528T | Diameter: 5.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-CLIS653T | Diameter: 6.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-T647T | Length: 47 Milliimeters | In distribution |
| L2-R612CHT | Diameter: 6.0 Milliimeters Length: 120 Milliimeters | In distribution |
| L2-L955T | Diameter: 5.5 Milliimeters | In distribution |
| L2-CH533T | Diameter: 5.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-T629T | Length: 29 Milliimeters | In distribution |
| L2-T620T | Length: 20 Milliimeters | In distribution |
| L2-R609T | Diameter: 6.0 Milliimeters Length: 90 Milliimeters | In distribution |
| L2-L865T | Diameter: 6.5 Milliimeters | In distribution |
| L2-C538T | Diameter: 5.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-RCS609LT | Diameter: 6.5 Milliimeters Length: 90 Milliimeters | In distribution |
| L2-R613HT | Length 135 mm | In distribution |
| L2-S758T | Diameter: 7.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-C838T | Diameter: 8.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-T650T | Length: 50 Milliimeters | In distribution |
| L2-C548T | Diameter: 5.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-T614T | Length: 87,5 Milliimeters Diameter: 4 Milliimeters | In distribution |
| L2-CLIS658T | Diameter: 6.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-T653T | Length: 53 Milliimeters | In distribution |
| L2-RCS608RT | Diameter: 6.5 Milliimeters Length: 80 Milliimeters | In distribution |
| L2-R604T | Diameter: 6.0 Milliimeters Length: 40 Milliimeters | In distribution |
| L2-R604HT | Diameter: 6.0 Milliimeters Length: 40 Milliimeters | In distribution |
| L2-R650HT | Diameter: 6.0 Milliimeters Length: 500 Milliimeters | In distribution |
| L2-C658T | Diameter: 6.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-C758T | Diameter: 7.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-RCS610LT | Diameter: 6.5 Milliimeters Length: 100 Milliimeters | In distribution |
| L2-S648T | Diameter: 6.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-C628T | Diameter: 6.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-RCS603RT | Diameter: 6.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-CH538T | Diameter: 5.5 Milliimeters Length: 38 Milliimeters | In distribution |
| L2-R642HT | Diameter: 6.0 Milliimeters Length: 420 Milliimeters | In distribution |
| L2-RCS606RT | Diameter: 6.5 Milliimeters Length: 60 Milliimeters | In distribution |
| L2-R611HT | Length 115 mm | In distribution |
| L2-S543T | Diameter: 5.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-C558T | Diameter: 5.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-RC605RT | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| L2-C648T | Diameter: 6.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-R614HT | Diameter: 6.0 Milliimeters Length: 140 Milliimeters | In distribution |
| L2-L201T | Diameter: 4,2 Milliimeters, Height: 6 Milliimeters | In distribution |
| L2-CLIS558T | Diameter: 5.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-L165T | Diameter: 6.5 Milliimeters | In distribution |
| L2-S553T | Diameter: 5.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-RCS609RT | Diameter: 6.5 Milliimeters Length: 90 Milliimeters | In distribution |
| L2-SH533T | Diameter: 5.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-T656T | Length: 56 Milliimeters | In distribution |
| L2-RC610RT | Diameter: 6.5 Milliimeters Length: 100 Milliimeters | In distribution |
| L2-S528T | Diameter: 5.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-RCS610RT | Diameter: 6.5 Milliimeters Length: 100 Milliimeters | In distribution |
| L2-R612HT | Diameter: 6.0 Milliimeters Length: 120 Milliimeters | In distribution |
| L2-R612T | Diameter: 6.0 Milliimeters Length: 120 Milliimeters | In distribution |
| L2-RCS612RT | Diameter: 6.5 Milliimeters Length: 120 Milliimeters | In distribution |
| L2-T641T | Length: 41 Milliimeters | In distribution |
| L2-R608T | Diameter: 6.0 Milliimeters Length: 80 Milliimeters | In distribution |
| L2-S643T | Diameter: 6.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-R614T | Diameter: 6.0 Milliimeters Length: 140 Milliimeters | In distribution |
| L2-CH558T | Diameter: 5.5 Milliimeters Length: 58 Milliimeters | In distribution |
| L2-RCS604RT | Diameter: 6.5 Milliimeters Length: 40 Milliimeters | In distribution |
| L2-RCS614LT | Diameter: 6.5 Milliimeters Length: 140 Milliimeters | In distribution |
| L2-R610CHT | Diameter: 6.0 Milliimeters Length: 100 Milliimeters | In distribution |
| L2-L855T | Diameter: 5.5 Milliimeters | In distribution |
| L2-RC612RT | Diameter: 6.5 Milliimeters Length: 120 Milliimeters | In distribution |
| L2-R604CHT | Diameter: 6.0 Milliimeters Length: 40 Milliimeters | In distribution |
| L2-T662T | Length: 62 Milliimeters | In distribution |
| L2-CLIS528T | Diameter: 5.5 Milliimeters Length: 28 Milliimeters | In distribution |
| L2-CLIS648T | Diameter: 6.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-S633T | Diameter: 6.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-C748T | Diameter: 7.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-RC608RT | Diameter: 6.5 Milliimeters Length: 80 Milliimeters | In distribution |
| L2-L655T | Diameter: 5.5 Milliimeters | In distribution |
| L2-CH548T | Diameter: 5.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-C643T | Diameter: 6.5 Milliimeters Length: 43 Milliimeters | In distribution |
| L2-R607HT | Diameter: 6.0 Milliimeters Length: 70 Milliimeters | In distribution |
| L2-S748T | Diameter: 7.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-RC607RT | Diameter: 6.5 Milliimeters Length: 70 Milliimeters | In distribution |
| L2-CLIS548T | Diameter: 5.5 Milliimeters Length: 48 Milliimeters | In distribution |
| L2-R625T | Diameter: 6.0 Milliimeters Length: 250 Milliimeters | In distribution |
| L2-L975T | Diameter: 7.5 Milliimeters | In distribution |
| L2-S653T | Diameter: 6.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-CLIS553T | Diameter: 5.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-RC603RT | Diameter: 6.5 Milliimeters Length: 28Milliimeters | In distribution |
| L2-R610HT | Diameter: 6.0 Milliimeters Length: 100 Milliimeters | In distribution |
| L2-CH553T | Diameter: 5.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-RCS607RT | Diameter: 6.5 Milliimeters Length: 70 Milliimeters | In distribution |
| L2-C533T | Diameter: 5.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-R605HT | Diameter: 6.0 Milliimeters Length: 50 Milliimeters | In distribution |
| L2-RCS614RT | Diameter: 6.5 Milliimeters Length: 140 Milliimeters | In distribution |
| L2-LSPL165T | Diameter: 6.5 Milliimeters | In distribution |
| L2-RC610LT | Diameter: 6.5 Milliimeters Length: 100 Milliimeters | In distribution |
| L2-T638T | Length: 38 Milliimeters | In distribution |
| L2-SH553T | Diameter: 5.5 Milliimeters Length: 53 Milliimeters | In distribution |
| L2-RCS605LT | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| L2-R660HT | Diameter: 6.0 Milliimeters Length: 600 Milliimeters | In distribution |
| L2-S533T | Diameter: 5.5 Milliimeters Length: 33 Milliimeters | In distribution |
| L2-RCS605RT | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| L2-RC605LT | Diameter: 6.5 Milliimeters Length: 50 Milliimeters | In distribution |
| L2-T626T | Length: 26 Milliimeters | In distribution |
| L2-RC606LT | Diameter: 6.5 Milliimeters Length: 60 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.