Trauma Fixation System
35 catalogue numbers from 245926, listed by Biomet Orthopedics, United States, under Screw, Fixation, Bone. 31 manufacturers in China are registered for this product code.
31manufacturers in China registered for this device type
35catalogue numbers in this listing
4510(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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K984209 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 245926 | 16MM THREAD 7.3MM Ø 105MM LENGTH | In distribution |
| 245964 | 32MM THREAD 7.3MM Ø 110MM LENGTH | In distribution |
| 245830 | 20MM THREAD 6.5MM Ø 45MM LENGTH | In distribution |
| 245906 | 16MM THREAD 7.3MM Ø 55MM LENGTH | In distribution |
| 245930 | 16MM THREAD 7.3MM Ø 115MM LENGTH | In distribution |
| 245950 | 32MM THREAD 7.3MM Ø 75MM LENGTH | In distribution |
| 245924 | 16MM THREAD 7.3MM Ø 100MM LENGTH | In distribution |
| 245938 | 32MM THREAD 7.3MM Ø 45MM LENGTH | In distribution |
| 245836 | 20MM THREAD 6.5MM Ø 60MM LENGTH | In distribution |
| 245936 | 32MM THREAD 7.3MM Ø 40MM LENGTH | In distribution |
| 245904 | 16MM THREAD 7.3MM Ø 50MM LENGTH | In distribution |
| 245902 | 16MM THREAD 7.3MM Ø 45MM LENGTH | In distribution |
| 245846 | 20MM THREAD 6.5MM Ø 85MM LENGTH | In distribution |
| 245962 | 32MM THREAD 7.3MM Ø 105MM LENGTH | In distribution |
| 245826 | 20MM THREAD 6.5MM Ø 35MM LENGTH | In distribution |
| 245856 | 20MM THREAD 6.5MM Ø 110MM LENGTH | In distribution |
| 245942 | 32MM THREAD 7.3MM Ø 55MM LENGTH | In distribution |
| 245972 | 13 MM | In distribution |
| 245956 | 32MM THREAD 7.3MM Ø 90MM LENGTH | In distribution |
| 245860 | 20MM THREAD 6.5MM Ø 120MM LENGTH | In distribution |
| 245854 | 20MM THREAD 6.5MM Ø 105MM LENGTH | In distribution |
| 245952 | 32MM THREAD 7.3MM Ø 80MM LENGTH | In distribution |
| 245908 | 16MM THREAD 7.3MM Ø 60MM LENGTH | In distribution |
| 245946 | 32MM THREAD 7.3MM Ø 65MM LENGTH | In distribution |
| 245918 | 16MM THREAD 7.3MM Ø 85MM LENGTH | In distribution |
| 245922 | 16MM THREAD 7.3MM Ø 95MM LENGTH | In distribution |
| 245940 | 32MM THREAD 7.3MM Ø 50MM LENGTH | In distribution |
| 245968 | 32MM THREAD 7.3MM Ø 120MM LENGTH | In distribution |
| 245848 | 20MM THREAD 6.5MM Ø 90MM LENGTH | In distribution |
| 245920 | 16MM THREAD 7.3MM Ø 90MM LENGTH | In distribution |
| 245970 | 32MM THREAD 7.3MM Ø 125MM LENGTH | In distribution |
| 245840 | 20MM THREAD 6.5MM Ø 70MM LENGTH | In distribution |
| 245828 | 20MM THREAD 6.5MM Ø 40MM LENGTH | In distribution |
| 245954 | 32MM THREAD 7.3MM Ø 85MM LENGTH | In distribution |
| 245824 | 20MM THREAD 6.5MM Ø 30MM LENGTH | 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 |
|---|---|
| K033355 | 2004-06-30 |
| K024086 | 2003-01-09 |
| K021254 | 2002-07-17 |
| K013534 | 2001-12-17 |
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.