TiLock
6.0mm x 40 mm TiLock Cortical Cannulated Reduction Screw
15manufacturers in China registered for this device type
909catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Genesys Orthopedics Systems, LLC |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K100757 |
| Record published | 2015-07-31 |
| Record revised | 2025-07-02 (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 8.5 to 600 mm; outer diameter 0.048 to 60 mm; length 45 µm |
| Distribution end date | 2026-06-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | Length 46 mm | In distribution |
| 1 | Length 280 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 190 mm | In distribution |
| 1 | Length 100 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 115 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 520 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 7.5 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 250 mm | In distribution |
| 1 | Length 550 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 110 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 220 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 35 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 50 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 36 mm | In distribution |
| 1 | Length 65 mm | In distribution |
| 1 | Length 95 mm | In distribution |
| 1 | Length 140 mm | In distribution |
| 1 | Length 440 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 120 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 480 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 100 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 60 mm | In distribution |
| 1 | Length 145 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 80 mm | In distribution |
| 1 | Length 260 mm | In distribution |
| 1 | Length 100 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 35 mm | In distribution |
| 1 | Length 75 mm | In distribution |
| 1 | Length 500 mm | In distribution |
| 1 | Length 340 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 40 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 115 mm | In distribution |
| 1 | Length 260 mm | In distribution |
| 1 | Length 175 mm | In distribution |
| 1 | Length 130 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 75 mm | In distribution |
| 1 | Length 65 mm | In distribution |
| 1 | Length 460 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 135 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Length 145 mm | In distribution |
| 1 | Length 220 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter.048 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 360 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 165 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 40 mm | In distribution |
| 1 | Length 155 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 420 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 125 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 145 mm | In distribution |
| 1 | 45-60mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 105 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 35 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 130 mm | In distribution |
| 1 | Length 80 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 70 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 85 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 155 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 600 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Length 70 mm | In distribution |
| 1 | Length 440 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 65 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 35 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 185 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 150 mm | In distribution |
| 1 | Length 65 mm | In distribution |
| 1 | Length 440 mm | In distribution |
| 1 | Length 195 mm | In distribution |
| 1 | Outer Diameter.062 mm | In distribution |
| 1 | Length 105 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 55 mm | In distribution |
| 1 | Outer Diameter.062 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 340 mm | In distribution |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | Length 105 mm | In distribution |
| 1 | Length 520 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 65 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 31 mm | In distribution |
| 1 | Length 125 mm | In distribution |
| 1 | Length 240 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 60 mm | In distribution |
| 1 | Length 200 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 190 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Outer Diameter 7.5 mm | In distribution |
| 1 | Length 75 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 250 mm | In distribution |
| 1 | Length 260 mm | In distribution |
| 1 | Length 130 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 190 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 450 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 80 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 155 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 185 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 480 mm | In distribution |
| 1 | Length 360 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 51 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 260 mm | In distribution |
| 1 | Length 175 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 60 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 200 mm | In distribution |
| 1 | Outer Diameter 6.0 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Outer Diameter.048 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 41 mm | In distribution |
| 1 | Length 400 mm | In distribution |
| 1 | Length 560 mm | In distribution |
| 1 | Outer Diameter.062 mm | In distribution |
| 1 | Length 50 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Genesys Spine | 510(k) number | 2014-04-02 | Class II | Nonconforming Material/Component | The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post | 642 | 2015-05-15 |
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.