U2 Total Knee System
Patellar capture, asymmetric onset, NON-CEM, XXL, Ø41mm
9manufacturers in China registered for this device type
23catalogue numbers in this listing
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 | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | HWR |
| Device type | Driver, Prosthesis |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-10-14 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9303-5710 | In distribution | |
| 9404-5420 | In distribution | |
| 9403-5101-RJ | In distribution | |
| 9404-5220-RA | In distribution | |
| 9404-5260-RA | In distribution | |
| 9323-5110 | In distribution | |
| 9404-5230-RA | In distribution | |
| 9404-5250-RA | In distribution | |
| 9404-5460 | In distribution | |
| 9404-5260 | In distribution | |
| 9403-5101 | In distribution | |
| 9404-5450 | In distribution | |
| 9404-5240-RA | In distribution | |
| 9404-5230 | In distribution | |
| 9403-5101-RH | In distribution | |
| 9303-5711 | In distribution | |
| 9404-5250 | In distribution | |
| 9303-5110-RT | In distribution | |
| 9304-8308-RB | In distribution | |
| 9404-5220 | In distribution | |
| 9404-5430 | In distribution | |
| 9404-5440 | In distribution | |
| 9404-5240 | 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 |
| 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
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.