Biodrive Screw System
157 catalogue numbers from 3214-065-080S, 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
157catalogue 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) | K082874 |
| 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 | Per pack | Status |
|---|---|---|---|
| 3214-065-080S | 6.5MM Ø 80MM LENGTH 32MM THREAD | In distribution | |
| 3214-075-050S | 7.5MM Ø 50MM LENGTH 32MM THREAD | In distribution | |
| 3212-040-038S | 4.0MM Ø 38MM LENGTH | In distribution | |
| 3214-075-100S | 7.5MM Ø 100MM LENGTH 32MM THREAD | In distribution | |
| 3214-075-075S | 7.5MM Ø 75MM LENGTH 32MM THREAD | In distribution | |
| 3213-065-055S | 6.5MM Ø 55MM LENGTH 16MM THREAD | In distribution | |
| 3211-040-030S | 4.0MM Ø 30MM LENGTH | In distribution | |
| 3213-065-085S | 6.5MM Ø 85MM LENGTH 16MM THREAD | In distribution | |
| 3214-075-120S | 7.5MM Ø 120MM LENGTH 32MM THREAD | In distribution | |
| 3212-050-038S | 5.0MM Ø 38MM LENGTH | In distribution | |
| 3211-040-022S | 4.0MM Ø 22MM LENGTH | In distribution | |
| 3212-040-034S | 4.0MM Ø 34MM LENGTH | In distribution | |
| 3211-040-036S | 4.0MM Ø 36MM LENGTH | In distribution | |
| 3214-065-125S | 6.5MM Ø 125MM LENGTH 32MM THREAD | In distribution | |
| 3214-075-080S | 7.5MM Ø 80MM LENGTH 32MM THREAD | In distribution | |
| 3112-028-028S | 2.8MM Ø 28MM LENGTH | In distribution | |
| 3112-035-036S | 3.5MM Ø 36MM LENGTH | In distribution | |
| 3214-065-100S | 6.5MM Ø 100MM LENGTH 32MM THREAD | In distribution | |
| 3213-075-095S | 7.5MM Ø 95MM LENGTH 16MM THREAD | In distribution | |
| 3212-050-030S | 5.0MM Ø 30MM LENGTH | In distribution | |
| 3214-065-040S | 6.5MM Ø 40MM LENGTH 32MM THREAD | In distribution | |
| 3212-050-044S | 5.0MM Ø 44MM LENGTH | In distribution | |
| 3213-065-070S | 6.5MM Ø 70MM LENGTH 16MM THREAD | In distribution | |
| 3212-050-040S | 5.0MM Ø 40MM LENGTH | In distribution | |
| 3213-065-130S | 6.5MM Ø 130MM LENGTH 16MM THREAD | In distribution | |
| 3212-040-026S | 4.0MM Ø 26MM LENGTH | In distribution | |
| 3212-050-048S | 5.0MM Ø 48MM LENGTH | In distribution | |
| 3212-040-018S | 4.0MM Ø 18MM LENGTH | In distribution | |
| 3212-050-046S | 5.0MM Ø 46MM LENGTH | In distribution | |
| 3214-075-090S | 7.5MM Ø 90MM LENGTH 32MM THREAD | In distribution | |
| 3213-065-110S | 6.5MM Ø 110MM LENGTH 16MM THREAD | In distribution | |
| 3112-028-030S | 2.8MM Ø 30MM LENGTH | In distribution | |
| 3214-065-090S | 6.5MM Ø 90MM LENGTH 32MM THREAD | In distribution | |
| 3213-065-050S | 6.5MM Ø 50MM LENGTH 16MM THREAD | In distribution | |
| 3112-035-040S | 3.5MM Ø 40MM LENGTH | In distribution | |
| 3213-065-105S | 6.5MM Ø 105MM LENGTH 16MM THREAD | In distribution | |
| 191153S | LARGE | 5 | In distribution |
| 3213-065-030S | 6.5MM Ø 30MM LENGTH 16MM THREAD | In distribution | |
| 3112-028-018S | 2.8MM Ø 18MM LENGTH | In distribution | |
| 3213-065-095S | 6.5MM Ø 95MM LENGTH 16MM THREAD | In distribution | |
| 3112-028-022S | 2.8MM Ø 22MM LENGTH | In distribution | |
| 3214-075-085S | 7.5MM Ø 85MM LENGTH 32MM THREAD | In distribution | |
| 3211-040-018S | 4.0MM Ø 18MM LENGTH | In distribution | |
| 3213-065-115S | 6.5MM Ø 115MM LENGTH 16MM THREAD | In distribution | |
| 3211-040-026S | 4.0MM Ø 26MM LENGTH | In distribution | |
| 3211-040-046S | 4.0MM Ø 46MM LENGTH | In distribution | |
| 3212-040-010S | 4.0MM Ø 10MM LENGTH | In distribution | |
| 3212-040-046S | 4.0MM Ø 46MM LENGTH | In distribution | |
| 3214-065-085S | 6.5MM Ø 85MM LENGTH 32MM THREAD | In distribution | |
| 3214-075-125S | 7.5MM Ø 125MM LENGTH 32MM THREAD | In distribution | |
| 3112-028-026S | 2.8MM Ø 26MM LENGTH | In distribution | |
| 3212-040-014S | 4.0MM Ø 14MM LENGTH | In distribution | |
| 3214-065-115S | 6.5MM Ø 115MM LENGTH 32MM THREAD | In distribution | |
| 3112-028-012S | 2.8MM Ø 12MM LENGTH | In distribution | |
| 191151S | SMALL | 5 | In distribution |
| 3214-065-055S | 6.5MM Ø 55MM LENGTH 32MM THREAD | In distribution | |
| 3212-050-024S | 5.0MM Ø 24MM LENGTH | In distribution | |
| 3214-065-050S | 6.5MM Ø 50MM LENGTH 32MM THREAD | In distribution | |
| 3213-065-125S | 6.5MM Ø 125MM LENGTH 16MM THREAD | In distribution | |
| 3112-035-026S | 3.5MM Ø 26MM LENGTH | In distribution | |
| 3213-075-085S | 7.5MM Ø 85MM LENGTH 16MM THREAD | In distribution | |
| 3211-040-050S | 4.0MM Ø 50MM LENGTH | In distribution | |
| 3211-040-048S | 4.0MM Ø 48MM LENGTH | In distribution | |
| 3214-065-120S | 6.5MM Ø 120MM LENGTH 32MM THREAD | In distribution | |
| 3214-075-130S | 7.5MM Ø 130MM LENGTH 32MM THREAD | In distribution | |
| 3213-065-060S | 6.5MM Ø 60MM LENGTH 16MM THREAD | In distribution | |
| 3211-040-032S | 4.0MM Ø 32MM LENGTH | In distribution | |
| 3213-065-080S | 6.5MM Ø 80MM LENGTH 16MM THREAD | In distribution | |
| 3213-075-070S | 7.5MM Ø 70MM LENGTH 16MM THREAD | In distribution | |
| 3213-075-075S | 7.5MM Ø 75MM LENGTH 16MM THREAD | In distribution | |
| 3112-035-034S | 3.5MM Ø 34MM LENGTH | In distribution | |
| 3212-040-012S | 4.0MM Ø 12MM LENGTH | In distribution | |
| 3212-050-026S | 5.0MM Ø 26MM LENGTH | In distribution | |
| 3212-050-060S | 5.0MM Ø 60MM LENGTH | In distribution | |
| 3212-040-022S | 4.0MM Ø 22MM LENGTH | In distribution | |
| 3112-035-014S | 3.5MM Ø 14MM LENGTH | In distribution | |
| 3213-065-035S | 6.5MM Ø 35MM LENGTH 16MM THREAD | In distribution | |
| 3214-075-110S | 7.5MM Ø 110MM LENGTH 32MM THREAD | In distribution | |
| 3214-065-070S | 6.5MM Ø 70MM LENGTH 32MM THREAD | In distribution | |
| 3214-075-040S | 7.5MM Ø 40MM LENGTH 32MM THREAD | In distribution | |
| 3212-050-070S | 5.0MM Ø 70MM LENGTH | In distribution | |
| 3213-075-100S | 7.5MM Ø 100MM LENGTH 16MM THREAD | In distribution | |
| 3213-065-040S | 6.5MM Ø 40MM LENGTH 16MM THREAD | In distribution | |
| 3211-040-016S | 4.0MM Ø 16MM LENGTH | In distribution | |
| 3211-040-034S | 4.0MM Ø 34MM LENGTH | In distribution | |
| 3213-065-075S | 6.5MM Ø 75MM LENGTH 16MM THREAD | In distribution | |
| 3211-040-020S | 4.0MM Ø 20MM LENGTH | In distribution | |
| 3212-040-030S | 4.0MM Ø 30MM LENGTH | In distribution | |
| 3211-040-028S | 4.0MM Ø 28MM LENGTH | In distribution | |
| 3112-035-032S | 3.5MM Ø 32MM LENGTH | In distribution | |
| 3112-028-016S | 2.8MM Ø 16MM LENGTH | In distribution | |
| 3211-040-038S | 4.0MM Ø 38MM LENGTH | In distribution | |
| 3213-075-080S | 7.5MM Ø 80MM LENGTH 16MM THREAD | In distribution | |
| 3214-065-110S | 6.5MM Ø 110MM LENGTH 32MM THREAD | In distribution | |
| 3214-065-045S | 6.5MM Ø 45MM LENGTH 32MM THREAD | In distribution | |
| 3214-075-115S | 7.5MM Ø 115MM LENGTH 32MM THREAD | In distribution | |
| 3211-040-024S | 4.0MM Ø 24MM LENGTH | In distribution | |
| 3214-075-065S | 7.5MM Ø 65MM LENGTH 32MM THREAD | In distribution | |
| 3212-050-022S | 5.0MM Ø 22MM LENGTH | In distribution | |
| 3212-040-050S | 4.0MM Ø 50MM LENGTH | In distribution | |
| 3112-035-024S | 3.5MM Ø 24MM LENGTH | In distribution | |
| 3212-050-028S | 5.0MM Ø 28MM LENGTH | In distribution | |
| 3214-075-055S | 7.5MM Ø 55MM LENGTH 32MM THREAD | In distribution | |
| 3214-075-045S | 7.5MM Ø 45MM LENGTH 32MM THREAD | In distribution | |
| 3212-050-036S | 5.0MM Ø 36MM LENGTH | In distribution | |
| 3212-050-034S | 5.0MM Ø 34MM LENGTH | In distribution | |
| 3212-050-042S | 5.0MM Ø 42MM LENGTH | In distribution | |
| 3112-028-024S | 2.8MM Ø 24MM LENGTH | In distribution | |
| 3214-075-070S | 7.5MM Ø 70MM LENGTH 32MM THREAD | In distribution | |
| 3212-040-042S | 4.0MM Ø 42MM LENGTH | In distribution | |
| 3112-035-016S | 3.5MM Ø 16MM LENGTH | In distribution | |
| 3211-040-014S | 4.0MM Ø 14MM LENGTH | In distribution | |
| 3214-075-060S | 7.5MM Ø 60MM LENGTH 32MM THREAD | In distribution | |
| 3112-035-018S | 3.5MM Ø 18MM LENGTH | In distribution | |
| 3212-040-036S | 4.0MM Ø 36MM LENGTH | In distribution | |
| 3214-065-060S | 6.5MM Ø 60MM LENGTH 32MM THREAD | In distribution | |
| 3212-050-050S | 5.0MM Ø 50MM LENGTH | In distribution | |
| 3211-040-040S | 4.0MM Ø 40MM LENGTH | In distribution | |
| 3112-035-038S | 3.5MM Ø 38MM LENGTH | In distribution | |
| 3211-040-044S | 4.0MM Ø 44MM LENGTH | In distribution | |
| 3214-065-105S | 6.5MM Ø 105MM LENGTH 32MM THREAD | In distribution | |
| 3213-075-090S | 7.5MM Ø 90MM LENGTH 16MM THREAD | In distribution | |
| 3212-040-028S | 4.0MM Ø 28MM LENGTH | In distribution | |
| 3212-040-016S | 4.0MM Ø 16MM LENGTH | In distribution | |
| 3212-040-024S | 4.0MM Ø 24MM LENGTH | In distribution | |
| 3213-065-090S | 6.5MM Ø 90MM LENGTH 16MM THREAD | In distribution | |
| 3214-075-105S | 7.5MM Ø 105MM LENGTH 32MM THREAD | In distribution | |
| 191152S | MEDIUM | 5 | In distribution |
| 3112-028-020S | 2.8MM Ø 20MM LENGTH | In distribution | |
| 3112-035-020S | 3.5MM Ø 20MM LENGTH | In distribution | |
| 3211-040-010S | 4.0MM Ø 10MM LENGTH | In distribution | |
| 3212-040-032S | 4.0MM Ø 32MM LENGTH | In distribution | |
| 3212-040-044S | 4.0MM Ø 44MM LENGTH | In distribution | |
| 3214-075-095S | 7.5MM Ø 95MM LENGTH 32MM THREAD | In distribution | |
| 3214-065-065S | 6.5MM Ø 65MM LENGTH 32MM THREAD | In distribution | |
| 3212-040-020S | 4.0MM Ø 20MM LENGTH | In distribution | |
| 3211-040-042S | 4.0MM Ø 42MM LENGTH | In distribution | |
| 3214-065-075S | 6.5MM Ø 75MM LENGTH 32MM THREAD | In distribution | |
| 3112-028-010S | 2.8MM Ø 10MM LENGTH | In distribution | |
| 3212-050-065S | 5.0MM Ø 65MM LENGTH | In distribution | |
| 3211-040-012S | 4.0MM Ø 12MM LENGTH | In distribution | |
| 3214-065-130S | 6.5MM Ø 130MM LENGTH 32MM THREAD | In distribution | |
| 3213-065-100S | 6.5MM Ø 100MM LENGTH 16MM THREAD | In distribution | |
| 3112-035-022S | 3.5MM Ø 22MM LENGTH | In distribution | |
| 3214-065-095S | 6.5MM Ø 95MM LENGTH 32MM THREAD | In distribution | |
| 3212-040-048S | 4.0MM Ø 48MM LENGTH | In distribution | |
| 3213-065-045S | 6.5MM Ø 45MM LENGTH 16MM THREAD | In distribution | |
| 3112-035-030S | 3.5MM Ø 30MM LENGTH | In distribution | |
| 3212-050-055S | 5.0MM Ø 55MM LENGTH | In distribution | |
| 3213-065-065S | 6.5MM Ø 65MM LENGTH 16MM THREAD | In distribution | |
| 3212-040-040S | 4.0MM Ø 40MM LENGTH | In distribution | |
| 3213-065-120S | 6.5MM Ø 120MM LENGTH 16MM THREAD | In distribution | |
| 3212-050-032S | 5.0MM Ø 32MM LENGTH | In distribution | |
| 3213-075-110S | 7.5MM Ø 110MM LENGTH 16MM THREAD | In distribution | |
| 3213-075-105S | 7.5MM Ø 105MM LENGTH 16MM THREAD | In distribution | |
| 3112-035-028S | 3.5MM Ø 28MM LENGTH | In distribution | |
| 3112-028-014S | 2.8MM Ø 14MM 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.