Integra® Ti6® Internal Fixation System
The Integra Ti6 Internal Fixation System is comprised of Headless screws used for bone fixation of the hand and foot following trauma or osteotomy. The titanium headless screw is a…
The Integra Ti6 Internal Fixation System is comprised of Headless screws used for bone fixation of the hand and foot following trauma or osteotomy. The titanium headless screw is a cannulated dual-thread, headless bone screw which is offered in 2.5 and 3.0mm diameters with lengths of 10 to 24mm. The titanium quick snap is a snap-off solid core screw which is offered in 2.0mm and 2.7mm diameters with lengths of 8 to 22mm.The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
31manufacturers in China registered for this device type
73catalogue 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DS2032 | 32 mm L x 2 mm dia; 10 mm thread | In distribution |
| TS4038 | 38 mm L x 4.0 mm dia; 14 mm thread | In distribution |
| TS4018 | 18 mm L x 4.0 mm dia; 8.5 mm thread | In distribution |
| TS4016 | 16 mm L x 4.0 mm dia; 7.5 mm thread | In distribution |
| DS2030 | 30 mm L x 2 mm dia; 9.5 mm thread | In distribution |
| TS2008 | 8 mm L x 2.04 mm dia; 3.5 mm thread | In distribution |
| TS2014 | 14 mm L x 2.04 mm dia; 5.5 mm thread | In distribution |
| TS2520 | 20 mm L x 2.5 mm dia; 8.60 mm thread | In distribution |
| TS2012 | 12 mm L x 2.04 mm dia; 4.5 mm thread | In distribution |
| DS2036 | 36 mm L x 2 mm dia; 11 mm thread | In distribution |
| TS3030 | 30 mm L x 3.0 mm dia; 11.75 mm thread | In distribution |
| TS2514 | 14 mm L x 2.5 mm dia; 6.60 mm thread | In distribution |
| TS3014 | 14 mm L x 3.0 mm dia; 6.25 mm thread | In distribution |
| DS2040 | 40 mm L x 2 mm dia; 12 mm thread | In distribution |
| TS2018 | 18 mm L x 2.04 mm dia; 6.5 mm thread | In distribution |
| TS3028 | 28 mm L x 3.0 mm dia; 11.75 mm thead | In distribution |
| TS3016 | 16 mm L x 3.0 mm dia; 6.75 mm thread | In distribution |
| TS2016 | 16 mm L x 2.04 mm dia; 6 mm thread | In distribution |
| TS2022 | 22 mm L x 2.04 mm dia; 8 mm thread | In distribution |
| TS4022 | 22 mm L x 4.0 mm dia; 9.5 mm thread | In distribution |
| TS3010 | 10 mm L x 3.0 mm dia; 5.75 mm thread | In distribution |
| TS2524 | 24 mm L x 2.5 mm dia; 10.10 mm thread | In distribution |
| TS4050 | 50 mm L x 4.0 mm dia; 15 mm thread | In distribution |
| TS2522 | 22 mm L x 2.5 mm dia; 9.10 mm thread | In distribution |
| DS2026 | 26 mm L x 2 mm dia; 8.5 mm thread | In distribution |
| DS2046 | 46 mm L x 2 mm dia; 13.5 mm thread | In distribution |
| TS4040 | 40 mm L x 4.0 mm dia; 14 mm thread | In distribution |
| DS2038 | 38 mm L x 2 mm dia; 11.5 mm thread | In distribution |
| TS3032 | 32 mm L x 3.0 mm dia; 11.75 mm thread | In distribution |
| TS3038 | 38 mm L x 3.0 mm dia; 13.75 mm thread | In distribution |
| TS4014 | 14 mm L x 4.0 mm dia; 7.5 mm thread | In distribution |
| TS3022 | 22 mm L x 3.0 mm dia; 9.75 mm thread | In distribution |
| TS2516 | 16 mm L x 2.5 mm dia; 7.10 mm thread | In distribution |
| TS2512 | 12 mm L x 2.5 mm dia; 6.10 mm thread | In distribution |
| TS4034 | 34 mm L x 4.0 mm dia; 13 mm thread | In distribution |
| TS2510 | 10 mm L x 2.5 mm dia; 5.10 mm thread | In distribution |
| TS2528 | 28 mm L x 2.5 mm dia; 11.10 mm thread | In distribution |
| TS3020 | 20 mm L x 3.0 mm dia; 8.75 mm thread | In distribution |
| TS3036 | 36 mm L x 3.0 mm dia; 12.75 mm thread | In distribution |
| TS2010 | 10 mm L x 2.04 mm dia; 4 mm thread | In distribution |
| TS4042 | 42 mm L x 4.0 mm dia; 14.5 mm thread | In distribution |
| TS2526 | 26 mm L x 2.5 mm dia; 10.10 mm thread | In distribution |
| DS2050 | 50 mm L x 2 mm dia; 14.5 mm thread | In distribution |
| TS2006 | 6 mm L x 2.04 mm dia; 3 mm thread | In distribution |
| TS2020 | 20 mm L x 2.04 mm dia; 7 mm thread | In distribution |
| TS2530 | 30 mm L x 2.5 mm dia; 12.10 mm thread | In distribution |
| DS2028 | 28 mm L x 2 mm dia; 9 mm thread | In distribution |
| TS4046 | 46 mm L x 4.0 mm dia; 14.5 mm thread | In distribution |
| DS2048 | 48 mm L x 2 mm dia; 14 mm thread | In distribution |
| TS3024 | 24 mm L x 3.0 mm dia; 9.75 mm thread | In distribution |
| TS3012 | 12 mm L x 3.0 mm dia; 5.75 mm thread | In distribution |
| TS4024 | 24 mm L x 4.0 mm dia; 10.5 mm thread | In distribution |
| TS4036 | 36 mm L x 4.0 mm dia; 14 mm thread | In distribution |
| TS4020 | 20 mm L x 4.0 mm dia; 9.5 mm thread | In distribution |
| TS2518 | 18 mm L x 2.5 mm dia; 8.10 mm thread | In distribution |
| TS3018 | 18 mm L x 3.0 mm dia; 7.75 mm thread | In distribution |
| TS4032 | 32 mm L x 4.0 mm dia; 13 mm thread | In distribution |
| DS2024 | 24 mm L x 2 mm dia; 8 mm thread | In distribution |
| TS3034 | 34 mm L x 3.0 mm dia; 12.75 mm thread | In distribution |
| DS2042 | 42 mm L x 2 mm dia; 12.5 mm thread | In distribution |
| TS4026 | 26 mm L x 4.0 mm dia; 11 mm thread | In distribution |
| TS3026 | 26 mm L x 3.0 mm dia; 10.75 mm thread | In distribution |
| DS2034 | 34 mm L x 2 mm dia; 10.5 mm thread | In distribution |
| TS4012 | 12 mm L x 4.0 mm dia; 7.5 mm thread | In distribution |
| TS3040 | 40 mm L x 3.0 mm dia; 13.75 mm thread | In distribution |
| TS4030 | 30 mm L x 4.0 mm dia; 12 mm thread | In distribution |
| DS2044 | 44 mm L x 2 mm dia; 13 mm thread | In distribution |
| TS4028 | 28 mm L x 4.0 mm dia; 12 mm thread | In distribution |
| TS2508 | 8 mm L x 2.5 mm dia; 5.10 mm thread | In distribution |
| TI6DIGITIMP | Withdrawn | |
| TI6SOLIDIMP | Withdrawn | |
| TI6HLESSIMP | Withdrawn | |
| TI6LOPROIMP | Withdrawn |
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.