Trauma Fixation Systems
53 catalogue numbers from 244738, 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
53catalogue 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 |
|---|---|---|
| 244738 | 3.5MM Ø 38MM LENGTH | In distribution |
| 244712 | 3.5MM Ø 12MM LENGTH | In distribution |
| 244744 | 3.5MM Ø 44MM LENGTH | In distribution |
| 245100 | 7.3MM Ø 100MM LENGTH FULL THREAD | In distribution |
| 245822 | 6.5MM Ø 25MM LENGTH | In distribution |
| 244722 | 3.5MM Ø 22MM LENGTH | In distribution |
| 245080 | 7.3MM Ø 80MM LENGTH FULL THREAD | In distribution |
| 244714 | 3.5MM Ø 14MM LENGTH | In distribution |
| 245085 | 7.3MM Ø 85MM LENGTH FULL THREAD | In distribution |
| 244710 | 3.5MM Ø 10MM LENGTH | In distribution |
| 244734 | 3.5MM Ø 34MM LENGTH | In distribution |
| 245842 | 6.5MM Ø 75MM LENGTH | In distribution |
| 245115 | 7.3MM Ø 115MM LENGTH FULL THREAD | In distribution |
| 244748 | 3.5MM Ø 48MM LENGTH | In distribution |
| 244724 | 3.5MM Ø 24MM LENGTH | In distribution |
| 245070 | 7.3MM Ø 70MM LENGTH FULL THREAD | In distribution |
| 245914 | 7.3MM Ø 75MM LENGTH | In distribution |
| 244732 | 3.5MM Ø 32MM LENGTH | In distribution |
| 244742 | 3.5MM Ø 42MM LENGTH | In distribution |
| 244736 | 3.5MM Ø 36MM LENGTH | In distribution |
| 245838 | 6.5MM Ø 65MM LENGTH | In distribution |
| 244718 | 3.5MM Ø 18MM LENGTH | In distribution |
| 244730 | 3.5MM Ø 30MM LENGTH | In distribution |
| 244720 | 3.5MM Ø 20MM LENGTH | In distribution |
| 245948 | 7.3MM Ø 70MM LENGTH | In distribution |
| 245966 | 7.3MM Ø 115MM LENGTH | In distribution |
| 245858 | 6.5MM Ø 115MM LENGTH | In distribution |
| 245850 | 6.5MM Ø 95MM LENGTH | In distribution |
| 245958 | 7.3MM Ø 95MM LENGTH | In distribution |
| 244728 | 3.5MM Ø 28MM LENGTH | In distribution |
| 245928 | 7.3MM Ø 110MM LENGTH | In distribution |
| 245900 | 7.3MM Ø 40MM LENGTH | In distribution |
| 245090 | 7.3MM Ø 90MM LENGTH FULL THREAD | In distribution |
| 244746 | 3.5MM Ø 46MM LENGTH | In distribution |
| 245916 | 7.3MM Ø 80MM LENGTH | In distribution |
| 244716 | 3.5MM Ø 16MM LENGTH | In distribution |
| 245934 | 7.3MM Ø 125MM LENGTH | In distribution |
| 245105 | 7.3MM Ø 105MM LENGTH FULL THREAD | In distribution |
| 245852 | 6.5MM Ø 100MM LENGTH | In distribution |
| 245075 | 7.3MM Ø 75MM LENGTH FULL THREAD | In distribution |
| 245844 | 6.5MM Ø 80MM LENGTH | In distribution |
| 245960 | 7.3MM Ø 100MM LENGTH | In distribution |
| 244726 | 3.5MM Ø 26MM LENGTH | In distribution |
| 245095 | 7.3 MM 95 MM | In distribution |
| 245932 | 7.3MM Ø 120MM LENGTH | In distribution |
| 244750 | 3.5MM Ø 50MM LENGTH | In distribution |
| 244740 | 3.5MM Ø 40MM LENGTH | In distribution |
| 245832 | 6.5MM Ø 50MM LENGTH | In distribution |
| 245912 | 7.3MM Ø 70MM LENGTH | In distribution |
| 245834 | 6.5MM Ø 55MM LENGTH | In distribution |
| 245110 | 7.3MM Ø 110MM LENGTH FULL THREAD | In distribution |
| 245910 | 7.3MM Ø 65MM LENGTH | In distribution |
| 245120 | 7.3MM Ø 120MM LENGTH FULL 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 |
|---|---|
| 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.