KangLi Pedicle Screw Spinal System
The KangLi pedicle screw spinal system uses screws, rods, nuts and crosslinks to stabilize and immobilize the spine during fusion with bone graft. It is intended for posterior, non-cervical…
The KangLi pedicle screw spinal system uses screws, rods, nuts and crosslinks to stabilize and immobilize the spine during fusion with bone graft. It is intended for posterior, non-cervical fixation in skeletally mature patients.
The fixation range extends from T8 through S1. The filed KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw is one screw option within the family, rather than a complete screw-and-rod construct.
Listed Item
KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.0×50mm
Implant Material and Supply
The components are made from Ti-6Al-4V ELI titanium alloy meeting ASTM F136. They are supplied nonsterile, with a validated hospital autoclave sterilization method. Component selection establishes the assembled construct; the family includes the connecting hardware as well as the pedicle screws.
13manufacturers in China registered for this device type
172catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Suzhou Kangli Orthopaedics Instrument Co., Ltd., China |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K142290 |
| Record published | 2016-09-03 |
| Record revised | 2024-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 25 to 460 mm |
| Distribution end date | 2016-09-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T6216045 | Diameter: 6.0 mm | In distribution |
| T6236050 | Diameter: 6.0 mm | In distribution |
| T6240170 | Diameter: 5.5 mm | In distribution |
| T6217040 | Diameter: 7.0 mm | In distribution |
| T6236545 | Diameter: 6.5 mm | In distribution |
| T6240050 | Diameter: 5.5 mm | In distribution |
| T6236555 | Diameter: 6.5 mm | In distribution |
| T6226040 | Diameter: 6.0 mm | In distribution |
| T6235555 | Diameter: 5.5 mm | In distribution |
| T6240200 | Diameter: 5.5 mm | In distribution |
| T6217045 | Diameter: 7.0 mm | In distribution |
| T6226035 | Diameter: 6.0 mm | In distribution |
| T6216035 | Diameter: 6.0 mm | In distribution |
| T6216555 | Diameter: 6.5 mm | In distribution |
| T6216550 | Diameter: 6.5 mm | In distribution |
| T6240180 | Diameter: 5.5 mm | In distribution |
| T6236540 | Diameter: 6.5 mm | In distribution |
| T6236550 | Diameter: 6.5 mm | In distribution |
| T6240120 | Diameter: 5.5 mm | In distribution |
| T6217035 | Diameter: 7.0 mm | In distribution |
| T6290070 | Diameter: 5.5 mm | In distribution |
| T6235535 | Diameter: 5.5 mm | In distribution |
| T6240100 | Diameter: 5.5 mm | In distribution |
| T6240160 | Diameter: 5.5 mm | In distribution |
| T6236535 | Diameter: 6.5 mm | In distribution |
| T6235540 | Diameter: 5.5 mm | In distribution |
| T6240460 | Diameter: 5.5 mm | In distribution |
| T6290080 | Diameter: 5.5 mm | In distribution |
| T6236030 | Diameter: 6.0 mm | In distribution |
| T6240340 | Diameter: 5.5 mm | In distribution |
| T6225545 | Diameter: 5.5 mm | In distribution |
| T6226550 | Diameter: 6.5 mm | In distribution |
| T6215540 | Diameter: 5.5 mm | In distribution |
| T6236040 | Diameter: 6.0 mm | In distribution |
| T6240130 | Diameter: 5.5 mm | In distribution |
| T6226535 | Diameter: 6.5 mm | In distribution |
| T6227040 | Diameter: 7.0 mm | In distribution |
| T6240190 | Diameter: 5.5 mm | In distribution |
| T6235530 | Diameter: 5.5 mm | In distribution |
| T6225540 | Diameter: 5.5 mm | In distribution |
| T6216040 | Diameter: 6.0 mm | In distribution |
| T6290060 | Diameter: 5.5 mm | In distribution |
| T6240280 | Diameter: 5.5 mm | In distribution |
| T6226540 | Diameter: 6.5 mm | In distribution |
| T6240055 | Diameter: 5.5 mm | In distribution |
| T6216535 | Diameter: 6.5 mm | In distribution |
| T6240240 | Diameter: 5.5 mm | In distribution |
| T6240220 | Diameter: 5.5 mm | In distribution |
| T6216050 | Diameter: 6.0 mm | In distribution |
| T6240260 | Diameter: 5.5 mm | In distribution |
| T6240060 | Diameter: 5.5 mm | In distribution |
| T6215535 | Diameter: 5.5 mm | In distribution |
| T6240070 | Diameter: 5.5 mm | In distribution |
| T6216545 | Diameter: 6.5 mm | In distribution |
| T6226050 | Diameter: 6.0 mm | In distribution |
| T6240080 | Diameter: 5.5 mm | In distribution |
| T6240150 | Diameter: 5.5 mm | In distribution |
| T6226045 | Diameter: 6.0 mm | In distribution |
| T6240110 | Diameter: 5.5 mm | In distribution |
| T6215545 | Diameter: 5.5 mm | In distribution |
| T6240380 | Diameter: 5.5 mm | In distribution |
| T6240090 | Diameter: 5.5 mm | In distribution |
| T6226545 | Diameter: 6.5 mm | In distribution |
| T6215530 | Diameter: 5.5 mm | In distribution |
| T6235550 | Diameter: 5.5 mm | In distribution |
| T6236045 | Diameter: 6.0 mm | In distribution |
| T6240320 | Diameter: 5.5 mm | In distribution |
| T6240300 | Diameter: 5.5 mm | In distribution |
| T6240400 | Diameter: 5.5 mm | In distribution |
| T6236035 | Diameter: 6.0 mm | In distribution |
| T6240140 | Diameter: 5.5 mm | In distribution |
| T6235545 | Diameter: 5.5 mm | In distribution |
| T6227035 | Diameter: 7.0 mm | In distribution |
| T6216540 | Diameter: 6.5 mm | In distribution |
| T6160400 | Diameter: 6.0 mm | Withdrawn |
| T5827045 | Diameter: 7.0 mm | Withdrawn |
| T5837035 | Diameter: 7.0 mm | Withdrawn |
| T5815545 | Diameter: 5.5 mm | Withdrawn |
| T6160170 | Diameter: 6.0 mm | Withdrawn |
| T6160100 | Diameter: 6.0 mm | Withdrawn |
| T6240360 | Diameter: 5.5 mm | Withdrawn |
| T5837550 | Diameter: 7.5 mm | Withdrawn |
| T6160060 | Diameter: 6.0 mm | Withdrawn |
| T6160070 | Diameter: 6.0 mm | Withdrawn |
| T5816540 | Diameter: 6.5 mm | Withdrawn |
| T5826555 | Diameter: 6.5 mm | Withdrawn |
| T6290050 | Diameter: 5.5 mm | Withdrawn |
| T5817545 | Diameter: 7.5 mm | Withdrawn |
| T5817035 | Diameter: 7.0 mm | Withdrawn |
| T6160300 | Diameter: 6.0 mm | Withdrawn |
| T5835540 | Diameter: 5.5 mm | Withdrawn |
| T5817540 | Diameter: 7.5 mm | Withdrawn |
| T6160090 | Diameter: 6.0 mm | Withdrawn |
| T6160340 | Diameter: 6.0 mm | Withdrawn |
| T5836525 | Diameter: 6.5 mm | Withdrawn |
| T5817535 | Diameter: 7.5 mm | Withdrawn |
| T5836530 | Diameter: 6.5 mm | Withdrawn |
| T5837040 | Diameter: 7.0 mm | Withdrawn |
| T6190070 | Diameter: 6.0 mm | Withdrawn |
| T5837540 | Diameter: 7.5 mm | Withdrawn |
| T5826535 | Diameter: 6.5 mm | Withdrawn |
| T6160110 | Diameter: 6.0 mm | Withdrawn |
| T5837545 | Diameter: 7.5 mm | Withdrawn |
| T6160160 | Diameter: 6.0 mm | Withdrawn |
| T5836535 | Diameter: 6.5 mm | Withdrawn |
| T5827545 | Diameter: 7.5 mm | Withdrawn |
| T6160130 | Diameter: 6.0 mm | Withdrawn |
| T5837050 | Diameter: 7.0 mm | Withdrawn |
| T6160220 | Diameter: 6.0 mm | Withdrawn |
| T5826050 | Diameter: 6.0 mm | Withdrawn |
| T6290090 | Diameter: 5.5 mm | Withdrawn |
| T5836050 | Diameter: 6.0 mm | Withdrawn |
| T5826550 | Diameter: 6.5 mm | Withdrawn |
| T6160055 | Diameter: 6.0 mm | Withdrawn |
| T5826545 | Diameter: 6.5 mm | Withdrawn |
| T5836555 | Diameter: 6.5 mm | Withdrawn |
| T5826035 | Diameter: 6.0 mm | Withdrawn |
| T5835545 | Diameter: 5.5 mm | Withdrawn |
| T5837535 | Diameter: 7.5 mm | Withdrawn |
| T5835530 | Diameter: 5.5 mm | Withdrawn |
| T6160280 | Diameter: 6.0 mm | Withdrawn |
| T5836540 | Diameter: 6.5 mm | Withdrawn |
| T5835535 | Diameter: 5.5 mm | Withdrawn |
| T5826540 | Diameter: 6.5 mm | Withdrawn |
| T6160320 | Diameter: 6.0 mm | Withdrawn |
| T6160380 | Diameter: 6.0 mm | Withdrawn |
| T6160150 | Diameter: 6.0 mm | Withdrawn |
| T5816050 | Diameter: 6.0 mm | Withdrawn |
| T5827035 | Diameter: 7.0 mm | Withdrawn |
| T6225535 | Diameter: 5.5 mm | Withdrawn |
| T5825545 | Diameter: 5.5 mm | Withdrawn |
| T6190090 | Diameter: 6.0 mm | Withdrawn |
| T5825535 | Diameter: 5.5 mm | Withdrawn |
| T5836550 | Diameter: 6.5 mm | Withdrawn |
| T5815540 | Diameter: 5.5 mm | Withdrawn |
| T5816550 | Diameter: 6.5 mm | Withdrawn |
| T5836035 | Diameter: 6.0 mm | Withdrawn |
| T6160240 | Diameter: 6.0 mm | Withdrawn |
| T5817040 | Diameter: 7.0 mm | Withdrawn |
| T5837045 | Diameter: 7.0 mm | Withdrawn |
| T6160040 | Diameter: 6.0 mm | Withdrawn |
| T6160080 | Diameter: 6.0 mm | Withdrawn |
| T6190080 | Diameter: 6.0 mm | Withdrawn |
| T6160120 | Diameter: 6.0 mm | Withdrawn |
| T5826040 | Diameter: 6.0 mm | Withdrawn |
| T5836045 | Diameter: 6.0 mm | Withdrawn |
| T6240045 | Length 45 mm | Withdrawn |
| T5836025 | Diameter: 6.0 mm | Withdrawn |
| T5827040 | Diameter: 7.0 mm | Withdrawn |
| T5816040 | Diameter: 6.0 mm | Withdrawn |
| T5816035 | Diameter: 6.0 mm | Withdrawn |
| T6160360 | Diameter: 6.0 mm | Withdrawn |
| T5816545 | Diameter: 6.5 mm | Withdrawn |
| T6160200 | Diameter: 6.0 mm | Withdrawn |
| T6190050 | Diameter: 6.0 mm | Withdrawn |
| T5836545 | Diameter: 6.5 mm | Withdrawn |
| T6190060 | Diameter: 6.0 mm | Withdrawn |
| T5815550 | Diameter: 5.5 mm | Withdrawn |
| T6160045 | Diameter: 6.0 mm | Withdrawn |
| T6160260 | Diameter: 6.0 mm | Withdrawn |
| T5836030 | Diameter: 6.0 mm | Withdrawn |
| T6160180 | Diameter: 6.0 mm | Withdrawn |
| T6160140 | Diameter: 6.0 mm | Withdrawn |
| T6160050 | Diameter: 6.0 mm | Withdrawn |
| T5815535 | Diameter: 5.5 mm | Withdrawn |
| T5826045 | Diameter: 6.0 mm | Withdrawn |
| T5825540 | Diameter: 5.5 mm | Withdrawn |
| T6160190 | Diameter: 6.0 mm | Withdrawn |
| T5816045 | Diameter: 6.0 mm | Withdrawn |
| T5816535 | Diameter: 6.5 mm | Withdrawn |
| T6160460 | Diameter: 6.0 mm | Withdrawn |
| T5827050 | Diameter: 7.0 mm | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142290 | 2014-11-24 |
| K140053 | 2014-06-26 |
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.