Integra®Ti6®
Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bone screw used in the Integra® Ti6® Internal Fixation System
31manufacturers in China registered for this device type
84catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K060026 |
| Record published | 2017-10-09 |
| Record revised | 2024-02-19 (version 6) |
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 |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TC4012 | 12 mm L x 3.9 mm dia; 6 mm thread | In distribution |
| TQ2716 | 2.27 in L x.109 in dia;.630 in thread | In distribution |
| TH3014 | 14 mm L x 3 mm dia; 6 mm thread | In distribution |
| TH3030 | 30 mm L x 3 mm dia; 14 mm thread | In distribution |
| TC4014 | 14 mm L x 3.9 mm dia; 6 mm thread | In distribution |
| TH3022 | 22 mm L x 3 mm dia; 10 mm thread | In distribution |
| TC4026 | 26 mm L x 3.9 mm dia; 9.5 mm thread | In distribution |
| TC3014 | 14 mm L x 3 mm dia; 5.5 mm thread | In distribution |
| TC4016 | 16 mm L x 3.9 mm dia; 6 mm thread | In distribution |
| TC3010 | 10 mm L x 3 mm dia; 5 mm thread | In distribution |
| TC4028 | 28 mm L x 3.9 mm dia; 10.5 mm thread | In distribution |
| TC2018 | 18 mm L x 2.10 mm dia; 6.5 mm thread | In distribution |
| TC3028 | 28 mm L x 3 mm dia; 10 mm thread | In distribution |
| TQ2712 | 2.112 in L x.109 in dia;.472 in thread | In distribution |
| TC2012 | 12 mm L x 2.10 mm dia; 4.5 mm thread | In distribution |
| TC2512 | 12 mm L x 2.6 mm dia; 5 mm thread | In distribution |
| TC3012 | 12 mm L x 3 mm dia; 5 mm thread | In distribution |
| TQ2014 | 1.731 in L x.083 in dia;.551 in thread | In distribution |
| TC2526 | 26 mm L x 2.6 mm dia; 9 mm thread | In distribution |
| TH3024 | 24 mm L x 3 mm dia; 11 mm thread | In distribution |
| TC4038 | 38 mm L x 3.9 mm dia; 12.5 mm thread | In distribution |
| TC4020 | 20 mm L x 3.9 mm dia; 8 mm thread | In distribution |
| TH2522 | 22 mm L x 2.5 mm dia; 10 mm thread | In distribution |
| TC3020 | 20 mm L x 3 mm dia; 8 mm thread | In distribution |
| TC3040 | 40 mm L x 3 mm dia; 13 mm thread | In distribution |
| TC2518 | 18 mm L x 2.6 mm dia; 7 mm thread | In distribution |
| TH3016 | 16 mm L x 3 mm dia; 7 mm thread | In distribution |
| TQ2714 | 2.191 in L x.109 in dia;.551 in thread | In distribution |
| TC2008 | 8 mm L x 2.10 mm dia; 3.5 mm thread | In distribution |
| TC4032 | 32 mm L x 3.9 mm dia; 11.5 thread | In distribution |
| TC2514 | 14 mm L x 2.6 mm dia; 5.5 mm thread | In distribution |
| TC4024 | 24 mm L x 3.9 mm dia; 9 mm thread | In distribution |
| TC2014 | 14 mm L x 2.10 mm dia; 5.5 mm thread | In distribution |
| TH2514 | 14 mm L x 2.5 mm dia; 6 mm thread | In distribution |
| TQ2016 | 1.81 in L x.083 in dia;.630 in thread | In distribution |
| TC2530 | 30 mm L x 2.6 mm dia; 10 mm thread | In distribution |
| TH2518 | 18 mm L x 2.5 mm dia; 8 mm thread | In distribution |
| TH3020 | 20 mm L x 3 mm dia; 9 mm thread | In distribution |
| TH3026 | 26 mm L x 3 mm dia; 12 mm thread | In distribution |
| TC2524 | 24 mm L x 2.6 mm dia; 9 mm thread | In distribution |
| TC3026 | 26 mm L x 3 mm dia; 10 mm thread | In distribution |
| TC4018 | 18 mm L x 3.9 mm dia; 7 mm thread | In distribution |
| TC4034 | 34 mm L x 3.9 mm dia; 11.5 mm thread | In distribution |
| TC2016 | 16 mm L x 2.10 mm dia; 6 mm thread | In distribution |
| TQ2008 | 1.495 in L x.083 in dia;.315 in thread | In distribution |
| TC3036 | 36 mm L x 3 mm dia; 12 mm thread | In distribution |
| TC3034 | 34 mm L x 3 mm dia; 12 mm thread | In distribution |
| TH3018 | 18 mm L x 3 mm dia; 8 mm thread | In distribution |
| TC2010 | 10 mm L x 2.10 mm dia; 4 mm thread | In distribution |
| TQ2011 | 1.613 in L x.083 in dia;.433 in thread | In distribution |
| TQ2718 | 2.349 in L x.109 in dia;.709 in thread | In distribution |
| TQ2012 | 1.652 in L x.083 in dia;.472 in thread | In distribution |
| TC2528 | 28 mm L x 2.6 mm dia; 10 mm thread | In distribution |
| TC2006 | 6 mm L x 2.10 mm dia; 3 mm thread | In distribution |
| TC4042 | 42 mm L x 3.9 mm dia; 13 mm thread | In distribution |
| TH3028 | 28 mm L x 3 mm dia; 13 mm thread | In distribution |
| TQ2010 | 1.574 in L x.083 in dia;.394 in thread | In distribution |
| TC4022 | 22 mm L x 3.9 mm dia; 8 mm thread | In distribution |
| TH2520 | 20 mm L x 2.5 mm dia; 9 mm thread | In distribution |
| TC3018 | 18 mm L x 3 mm dia; 7 mm thread | In distribution |
| TC2508 | 8 mm L x 2.6 mm dia; 4 mm thread | In distribution |
| TQ2720 | 2.427 in L x.109 in dia;.787 in thread | In distribution |
| TC3024 | 24 mm L x 3 mm dia; 9 mm thread | In distribution |
| TC4036 | 36 mm L x 3.9 mm dia; 12.5 mm thread | In distribution |
| TQ2722 | 2.506 in L x.109 in dia;.866 in thread | In distribution |
| TC3032 | 32 mm L x 3 mm dia; 11 mm thread | In distribution |
| TC3030 | 30 mm L x 3 mm dia; 11 mm thread | In distribution |
| TC2516 | 16 mm L x 2.6 mm dia; 6 mm thread | In distribution |
| TC2020 | 20 mm L x 2.10 mm dia; 7 mm thread | In distribution |
| TH2512 | 12 mm L x 2.5 mm dia; 4.85 mm thread | In distribution |
| TC4030 | 30 mm L x 3.9 mm dia; 10.5 mm thread | In distribution |
| TC3016 | 16 mm L x 3 mm dia; 6 mm thread | In distribution |
| TH2510 | 10 mm L x 2.5 mm dia; 2.85 mm thread | In distribution |
| TC2510 | 10 mm L x 2.6 mm dia; 4 mm thread | In distribution |
| TC2022 | 22 mm L x 2.10 mm dia; 7.5 mm thread | In distribution |
| TH2516 | 16 mm L x 2.5 mm dia; 7 mm thread | In distribution |
| TC2522 | 22 mm L x 2.6 mm dia; 8 mm thread | In distribution |
| TC2520 | 20 mm L x 2.6 mm dia; 7.5 mm thread | In distribution |
| TC3022 | 22 mm L x 3 mm dia; 9 mm thread | In distribution |
| TC4050 | 50 mm L x 3.9 mm dia; 13.5 mm thread | In distribution |
| TC4046 | 46 mm L x 3.9 mm dia; 13 mm thread | In distribution |
| TH3032 | 32 mm L x 3 mm dia; 15 mm thread | In distribution |
| TC4040 | 40 mm L x 3.9 mm dia; 12.5 mm thread | In distribution |
| TH3034 | 34 mm L x 3 mm dia; 16 mm thread | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162153 | 2017-07-14 |
| K152527 | 2015-10-29 |
| K092440 | 2009-11-05 |
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.