Talon™ Compression Hip Screw System
Side Plate, 130 Deg x 38mm, Standard Barrel, 4 Hole
31manufacturers in China registered for this device type
43catalogue numbers in this listing
1510(k) clearance
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 | Orthopedic Designs North America, 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) | K984331 |
| Record published | 2015-10-22 |
| Record revised | 2024-02-19 (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, manufacturing date |
| Sizes | Length 26 to 125 mm; outer diameter 4.5 to 12.7 mm; angle 130 to 150 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| THS130384 | 4 Hole | In distribution |
| THS045034 | Outer Diameter 4.5 mm | In distribution |
| THS004026` | Length 26 mm | In distribution |
| THS127120 | Outer Diameter 12.7 mm | In distribution |
| THS045050 | Outer Diameter 4.5 mm | In distribution |
| THS045046 | Outer Diameter 4.5 mm | In distribution |
| THS045056 | Length 56 mm | In distribution |
| THS127115 | Length 115 mm | In distribution |
| THS045048 | Length 48 mm | In distribution |
| THS004032 | Length 32 mm | In distribution |
| THS127065 | Length 65 mm | In distribution |
| THS145384 | Standard Barrel (38mm) | In distribution |
| THS127090 | Outer Diameter 12.7 mm | In distribution |
| THS150254 | 4 Hole | In distribution |
| THS127095 | Length 95 mm | In distribution |
| THS045028 | Length 28 mm | In distribution |
| THS127105 | Length 105 mm | In distribution |
| THS127085 | Length 85 mm | In distribution |
| THS045054 | Outer Diameter 4.5 mm | In distribution |
| THS127070 | Outer Diameter 12.7 mm | In distribution |
| THS045042 | Outer Diameter 4.5 mm | In distribution |
| THS135254 | Short Barrel (25mm) | In distribution |
| THS127125 | Length 125 mm | In distribution |
| THS135386 | Standard Barrel (38mm) | In distribution |
| THS127100 | Outer Diameter 12.7 mm | In distribution |
| THS140384 | 4 Hole | In distribution |
| THS045052 | Length 52 mm | In distribution |
| THS150386 | Standard Barrel (38mm) | In distribution |
| THS135384 | Standard Barrel (38mm) | In distribution |
| THS127110 | Outer Diameter 12.7 mm | In distribution |
| THS045040 | Length 40 mm | In distribution |
| THS045036 | Length 36 mm | In distribution |
| THS127075 | Length 75 mm | In distribution |
| THS045038 | Outer Diameter 4.5 mm | In distribution |
| THS135388 | 8 Hole | In distribution |
| THS127080 | Outer Diameter 12.7 mm | In distribution |
| THS045030 | Outer Diameter 4.5 mm | In distribution |
| THS135383 | 3 Hole | In distribution |
| THS045032 | Length 32 mm | In distribution |
| THS045044 | Length 44 mm | In distribution |
| THS045026 | Outer Diameter 4.5 mm | In distribution |
| THS150384 | 4 Hole | In distribution |
| THS135382 | Standard Barrel (38mm) | 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 |
|---|---|
| K210146 | 2022-04-13 |
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.