Streamline TL Spinal Fixation System
Strmln TL Yoke Capture RS Setscrew Inrtr
9manufacturers in China registered for this device type
23catalogue 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 | Pioneer Surgical Technology, Inc., United States |
|---|---|
| FDA product code | HWR |
| Device type | Driver, Prosthesis |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-25 |
| Record revised | 2026-01-29 (version 8) |
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 | 2024-05-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 724-444 | Withdrawn | |
| 724-300 | Withdrawn | |
| 724-246 | Withdrawn | |
| 722-630 | Withdrawn | |
| 724-440 | Withdrawn | |
| 724-244 | Withdrawn | |
| 722-375 | Withdrawn | |
| 724-861 | Withdrawn | |
| 02-RS-INSERTER | Withdrawn | |
| 724-112 | Withdrawn | |
| 724-918 | Withdrawn | |
| 723-877 | Withdrawn | |
| 724-538 | Withdrawn | |
| 724-008 | Withdrawn | |
| 723-858 | Withdrawn | |
| 724-252 | Withdrawn | |
| 724-387 | Withdrawn | |
| 02-SCREWINSRTR-CL | Withdrawn | |
| 02-SETSCRWINS-1 | Withdrawn | |
| 02-SCREWINSRTR | Withdrawn | |
| 02-SETSCRWINS-2 | Withdrawn | |
| 724-299 | Withdrawn | |
| 02-RS-SCREWINSRTR | Withdrawn |
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 |
| 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 |
| General Instruments | 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 |
|---|---|---|---|---|---|
| 2007-10-10 | Not classified | Component change control | The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient. | 38 | 2008-03-31 |
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.