U2™ Knee
Straight stem reamer, Ø23mm
23manufacturers in China registered for this device type
41catalogue 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 | 2017-06-29 |
| 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 |
|---|---|---|
| 9403-3023-RB | Ø23mm | In distribution |
| 9403-3020-RB | Ø20mm | In distribution |
| 9404-4711 | S | In distribution |
| 9403-3010 | φ10mm | In distribution |
| 9403-3022-RB | Ø22mm | In distribution |
| 9403-3012 | φ12mm | In distribution |
| 9403-3015-RB | Ø15mm | In distribution |
| 9404-4712 | M | In distribution |
| 9403-3009 | φ9mm | In distribution |
| 9303-3205 | φ3.2mm×120mm | In distribution |
| 9303-3201 | short | In distribution |
| 9303-3202 | long | In distribution |
| 9403-3015 | φ15mm | In distribution |
| 9404-4713 | L | In distribution |
| 9403-3021-RB | Ø21mm | In distribution |
| 9403-3009-RB | Ø9mm | In distribution |
| 9403-3018 | φ18mm | In distribution |
| 9303-3200 | 400mm | In distribution |
| 9403-3016-RB | Ø16mm | In distribution |
| 9403-3019-RB | Ø19mm | In distribution |
| 9403-3302 | 2mm | In distribution |
| 9403-3024-RB | Ø24mm | In distribution |
| 9303-4101-RH | In distribution | |
| 9403-3011 | φ11mm | In distribution |
| 9404-4714 | XL | In distribution |
| 9304-4101 | In distribution | |
| 9403-3017 | φ17mm | In distribution |
| 9403-3011-RB | Ø11mm | In distribution |
| 9303-4101-RF | In distribution | |
| 9403-3014-RB | Ø14mm | In distribution |
| 9403-3010-RB | Ø10mm | In distribution |
| 9403-3013 | φ13mm | In distribution |
| 9403-3012-RB | Ø12mm | In distribution |
| 9403-3016 | φ16mm | In distribution |
| 9403-3304 | 4mm | In distribution |
| 9403-3018-RB | Ø18mm | In distribution |
| 9403-3017-RB | Ø17mm | In distribution |
| 9403-3013-RB | Ø13mm | In distribution |
| 9403-3014 | φ14mm | In distribution |
| 9304-4101-RA | In distribution | |
| 9403-3300 | 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.