U2™ Hip
Revision hip stem straight reamer, Ø15.5
23manufacturers in China registered for this device type
94catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Zhejiang (3). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Showing 12 of 23. All 23 manufacturers in China registered for Reamer
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-06-26 |
| Record revised | 2023-10-04 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9203-4036 | 36mm | In distribution |
| 9104-3209 | Ø9.5 | In distribution |
| 9203-4039 | 39mm | In distribution |
| 9104-3611 | Ø11.5mm | In distribution |
| 9104-3008 | Ø8mm | In distribution |
| 9104-3014 | Ø14mm | In distribution |
| 9104-3617 | Ø17.5mm | In distribution |
| 9104-3511 | Ø11mm | In distribution |
| 9203-4051 | 51mm | In distribution |
| 9203-4069 | 69mm | In distribution |
| 9104-3515 | Ø15mm | In distribution |
| 9203-4059 | 59mm | In distribution |
| 9203-4048 | 46mm | In distribution |
| 9104-3112 | Ø12.0 | In distribution |
| 9104-3215 | Ø15.5 | In distribution |
| 9104-3012 | Ø12mm | In distribution |
| 9104-4040 | φ40mm | In distribution |
| 9104-3113 | Ø13.0 | In distribution |
| 9104-3516 | Ø16mm | In distribution |
| 9104-3523 | Ø23mm | In distribution |
| 9203-4060 | 60mm | In distribution |
| 9104-3213 | Ø13.5 | In distribution |
| 9104-3518 | Ø18mm | In distribution |
| 9203-4040 | 40mm | In distribution |
| 9203-4062 | 62mm | In distribution |
| 9104-3620 | Ø20.5mm | In distribution |
| 9203-4065 | 65mm | In distribution |
| 9104-3210 | Ø10.5 | In distribution |
| 9203-4055 | 55mm | In distribution |
| 9104-3214 | Ø14.5 | In distribution |
| 9104-3108 | Ø8.0 | In distribution |
| 9104-3216 | Ø16.5 | In distribution |
| 9104-3217 | Ø17.5 | In distribution |
| 9104-3513 | Ø13mm | In distribution |
| 9203-4047 | 47mm | In distribution |
| 9203-4045 | 45mm | In distribution |
| 9104-3211 | Ø11.5 | In distribution |
| 9104-3517 | Ø17mm | In distribution |
| 9203-4053 | 53mm | In distribution |
| 9104-3514 | Ø14mm | In distribution |
| 9104-3519 | Ø19mm | In distribution |
| 9203-4058 | 58mm | In distribution |
| 9203-4054 | 54mm | In distribution |
| 9203-4061 | 61mm | In distribution |
| 9203-4050 | 49mm | In distribution |
| 9104-3622 | Ø22.5mm | In distribution |
| 9203-4046 | 46mm | In distribution |
| 9104-3618 | Ø18.5mm | In distribution |
| 9104-3621 | Ø21.5mm | In distribution |
| 9104-3114 | Ø14.0 | In distribution |
| 9203-4067 | 67mm | In distribution |
| 9203-4041 | 41mm | In distribution |
| 9104-3610 | Ø10.5mm | In distribution |
| 9203-4052 | 52mm | In distribution |
| 9104-3115 | Ø15.0 | In distribution |
| 9203-4068 | 68mm | In distribution |
| 9104-3521 | Ø21mm | In distribution |
| 9104-3613 | Ø13.5mm | In distribution |
| 9104-3116 | Ø16.0 | In distribution |
| 9104-3614 | Ø14.5mm | In distribution |
| 9203-4070 | 70mm | In distribution |
| 9203-4044 | 44mm | In distribution |
| 9104-3510 | Ø10mm | In distribution |
| 9203-4066 | 66mm | In distribution |
| 9203-4038 | 38mm | In distribution |
| 9104-3015 | Ø15mm | In distribution |
| 9104-3619 | Ø19.5mm | In distribution |
| 9104-3111 | Ø11.0 | In distribution |
| 9203-4063 | 63mm | In distribution |
| 9104-3110 | Ø10.0 | In distribution |
| 9104-3520 | Ø20mm | In distribution |
| 9104-3509 | Ø9mm | In distribution |
| 9203-4037 | 37mm | In distribution |
| 9104-3616 | Ø16.5mm | In distribution |
| 9104-3118 | Ø18.0 | In distribution |
| 9104-3615 | Ø15.5mm | In distribution |
| 9104-3623 | Ø23.5mm | In distribution |
| 9203-4042 | 42mm | In distribution |
| 9104-3522 | Ø22mm | In distribution |
| 9104-3013 | Ø13mm | In distribution |
| 9104-3009 | Ø9mm | In distribution |
| 9104-3011 | Ø11mm | In distribution |
| 9104-3117 | Ø17.0 | In distribution |
| 9203-4056 | 56mm | In distribution |
| 9104-3109 | Ø9.0 | In distribution |
| 9203-4057 | 57mm | In distribution |
| 9203-4043 | 43mm | In distribution |
| 9104-3524 | Ø24mm | In distribution |
| 9104-3212 | Ø12.5 | In distribution |
| 9104-3609 | Ø9.5mm | In distribution |
| 9104-3512 | Ø12mm | In distribution |
| 9203-4064 | 64mm | In distribution |
| 9203-4049 | 49mm | In distribution |
| 9104-3010 | Ø10mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trigen | Smith & Nephew, Inc. | 1,029 |
| Viant Medical, LLC | Viant Medical, LLC | 825 |
| R3 | Smith & Nephew, Inc. | 287 |
| Reamer | Ortho Development Corp. | 259 |
| InSitu Hip System | Nextstep Arthropedix | 181 |
| Apex Knee System | Omni Life Science, Inc. | 162 |
| Reamer | Synthes Gmbh | 152 |
| Reclaim | Depuy (Ireland) | 138 |
| Reamer | Zimmer, Inc. | 135 |
| Endo-Model Knee System – Instruments | Waldemar Link GmbH & Co. KG | 109 |
| DJO Surgical | Encore Medical, L.P. | 108 |
| Arthrex® | Arthrex, Inc. | 105 |
Showing 12 of 1,224. All products under Reamer
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.