Driver, Prosthesis
Driver Star 10 Self Retaining
9manufacturers in China registered for this device type
14catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (2), Shanghai (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Jiangsu Kersen Medical Instrument Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 3 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | HWR |
| Device type | Driver, Prosthesis |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-17 |
| Record revised | 2023-09-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 49510055 | In distribution | |
| 86PS3014 | 2mm | In distribution |
| 40251101 | Star 10 | In distribution |
| RR3027 | In distribution | |
| RRM5007 | In distribution | |
| 58861T15 | Star 15 | In distribution |
| 86PS3016 | Size: 6 | In distribution |
| 40251100 | Star 10 | In distribution |
| 57LPDT20 | Size: T20 | In distribution |
| 9945007000 | Angled | In distribution |
| RR3029 | In distribution | |
| EFSR5002 | Size: 3.5mm | In distribution |
| 03-5010 | In distribution | |
| 86PS3017 | Size: 7-8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Driver, Prosthesis | Depuy Spine, Inc. | 270 |
| ACE | Ace Surgical Supply Co., Inc. | 64 |
| Expedium | Medos International Sàrl | 54 |
| Moss | Depuy Spine, Inc. | 33 |
| Acumed | Acumed LLC | 24 |
| Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 23 |
| U2 Total Knee System | United Orthopedic Corp. | 23 |
| Driver, Prosthesis | Zimmer, Inc. | 22 |
| Viper | Depuy Spine, Inc. | 21 |
| X-Mesh | Depuy Spine, Inc. | 20 |
| Driver, Prosthesis | Depuy (Ireland) | 18 |
| Invictus | Alphatec Spine, Inc. | 18 |
Showing 12 of 390. All products under Driver, Prosthesis
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 |
|---|---|---|---|---|---|
| 2007-10-04 | Not classified | Device Design | Breakage: breaking of the connecting foot that is on the distal surface of the instrument | 66 units | 2009-07-22 |
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.