VSP
VSP SPINE SYSTEM BONE SCREW STANDARD 4.75 x 35mm
31manufacturers in China registered for this device type
1catalogue number
15recalls on this 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 | Depuy Spine, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K875053 |
| Record published | 2015-09-24 |
| Record revised | 2025-07-02 (version 6) |
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 |
| Distribution end date | 2018-06-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22261935 | Withdrawn |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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 715 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 948 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 1720 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 4843 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 87 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 635 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 66 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 86 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 21 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 6740 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 2272 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 86 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 249 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 157 units | 2017-03-27 |
| 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 243 units | 2017-03-27 |
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.