TiLock
TiLock2-Benvenue MIS Instrument Outer Case
13manufacturers in China registered for this device type
217catalogue 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 | Genesys Orthopedics Systems, LLC |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K100757 |
| Record published | 2015-07-31 |
| Record revised | 2025-07-02 (version 4) |
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 11 to 500 mm; outer diameter 0.048 to 8.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Length 140 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 30 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 300 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter.062 mm | In distribution |
| 1 | Outer Diameter.048 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter.062 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 60 mm | In distribution |
| 1 | Length 150 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 380 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 480 mm | In distribution |
| 1 | Length 95 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 36 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 170 mm | In distribution |
| 1 | Length 110 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 420 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 16 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 40 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 41 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | Length 160 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 46 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 31 mm | In distribution |
| 1 | Length 11 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 240 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 75 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 190 mm | In distribution |
| 1 | Length 280 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 480 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 45 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 500 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 25 mm | In distribution |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 51 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 440 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 450 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 90 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 7.5 mm | In distribution |
| 1 | Length 11 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 130 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter.062 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter.048 mm | In distribution |
| 1 | Length 95 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 320 mm | In distribution |
| 1 | Length 85 mm | In distribution |
| 1 | Length 280 mm | In distribution |
| 1 | Length 360 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 190 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 340 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 200 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 220 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 31 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 60 mm | In distribution |
| 1 | Length 21 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 170 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | Length 250 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | Outer Diameter.062 mm | In distribution |
| 1 | Outer Diameter 8.13 mm | In distribution |
| 1 | Length 70 mm | In distribution |
| 1 | Length 460 mm | In distribution |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | Outer Diameter 5.5 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 260 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 65 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter.062 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 320 mm | In distribution |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter.048 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 40 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 21 mm | In distribution |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | Outer Diameter 7.5 mm | In distribution |
| 1 | Length 150 mm | In distribution |
| 1 | Length 220 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 400 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 8.5 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 420 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 380 mm | In distribution |
| 1 | Outer Diameter.048 mm | In distribution |
| 1 | In distribution | |
| 1 | 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
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.