Apex Knee System
Apex Revision Knee Reamer – ZIMMER LONG FLUTES, 12.5mm
23manufacturers in China registered for this device type
162catalogue 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 | Omni Life Science, Inc., United States |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2023-01-10 |
| Record revised | 2023-10-04 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XK-07173 | In distribution | |
| KR-52140 | In distribution | |
| KR-52190 | In distribution | |
| XK704813 | In distribution | |
| KR-50155 | In distribution | |
| KR-53150 | In distribution | |
| KR-50105-R | In distribution | |
| KR-51210 | In distribution | |
| KS-66001 | In distribution | |
| KR-50145 | In distribution | |
| KR-54140 | In distribution | |
| KS-67070 | In distribution | |
| KR-54100 | In distribution | |
| KR-54200 | In distribution | |
| KR-50095 | In distribution | |
| WS-40035 | In distribution | |
| XK704816 | In distribution | |
| KR-53130 | In distribution | |
| KS-99130 | In distribution | |
| KR-50205 | In distribution | |
| KR-50185 | In distribution | |
| KR-50085 | In distribution | |
| XK-67911 | In distribution | |
| KS-67040 | In distribution | |
| KR-50230 | In distribution | |
| KS-67062 | In distribution | |
| KR-54230 | In distribution | |
| KR-50165 | In distribution | |
| KR-52240 | In distribution | |
| KR-50175 | In distribution | |
| KR-50250 | In distribution | |
| WS-40226 | In distribution | |
| KR-51120 | In distribution | |
| KR-50235 | In distribution | |
| KR-54260 | In distribution | |
| KR-52200 | In distribution | |
| KR-53140 | In distribution | |
| KR-50160 | In distribution | |
| KR-50005 | In distribution | |
| XK704814 | In distribution | |
| KR-50225 | In distribution | |
| KS-66011 | In distribution | |
| KR-50220 | In distribution | |
| KS-66010 | In distribution | |
| KR-50240 | In distribution | |
| KR-51230 | In distribution | |
| KR-54130 | In distribution | |
| KR-52260 | In distribution | |
| KS-66002 | In distribution | |
| KR-51190 | In distribution | |
| KR-50100 | In distribution | |
| KR-50185-R | In distribution | |
| KR-50000 | In distribution | |
| WS-40026 | In distribution | |
| KR-50265 | In distribution | |
| KR-51240 | In distribution | |
| KR-50245 | In distribution | |
| KR-54210 | In distribution | |
| XK-07023 | In distribution | |
| KR-53190 | In distribution | |
| KR-53180 | In distribution | |
| KS-99134 | In distribution | |
| KR-52130 | In distribution | |
| KR-53120 | In distribution | |
| KR-53200 | In distribution | |
| KR-50190 | In distribution | |
| KR-51125 | In distribution | |
| KS-66506 | In distribution | |
| KR-54250 | In distribution | |
| KR-52150 | In distribution | |
| XK704817 | In distribution | |
| XK-72417 | In distribution | |
| KR-52110 | In distribution | |
| KR-51100 | In distribution | |
| KS-66102 | In distribution | |
| KR-51220 | In distribution | |
| KR-50200 | In distribution | |
| WS-40032 | In distribution | |
| KR-50120 | In distribution | |
| KS-99109 | In distribution | |
| KR-54110 | In distribution | |
| KR-50090 | In distribution | |
| KR-52220 | In distribution | |
| XK-67915 | In distribution | |
| KR-54120 | In distribution | |
| KR-50140 | In distribution | |
| KS-66003 | In distribution | |
| KR-53100 | In distribution | |
| KR-54150 | In distribution | |
| KR-52180 | In distribution | |
| KS-66304 | In distribution | |
| KR-53250 | In distribution | |
| KR-50105 | In distribution | |
| KR-50170 | In distribution | |
| KR-51200 | In distribution | |
| KS-99132 | In distribution | |
| KR-52230 | In distribution | |
| KR-54220 | In distribution | |
| KR-50255 | In distribution | |
| KR-51260 | In distribution | |
| XK-67913 | In distribution | |
| KR-50145-R | In distribution | |
| KR-52120 | In distribution | |
| KS-99113 | In distribution | |
| XK-72413 | In distribution | |
| KR-52100 | In distribution | |
| KR-53210 | In distribution | |
| KR-50195 | In distribution | |
| KR-53260 | In distribution | |
| XK704811 | In distribution | |
| KR-50210 | In distribution | |
| KR-53240 | In distribution | |
| KR-51130 | In distribution | |
| KR-50110 | In distribution | |
| KR-51170 | In distribution | |
| KR-50125-R | In distribution | |
| KR-50130 | In distribution | |
| KR-51140 | In distribution | |
| KR-51150 | In distribution | |
| KR-51250 | In distribution | |
| KR-51160 | In distribution | |
| KR-50135 | In distribution | |
| KR-54160 | In distribution | |
| KR-51110 | In distribution | |
| WS-40050 | In distribution | |
| XK704812 | In distribution | |
| KS-99112 | In distribution | |
| KR-53220 | In distribution | |
| XK-72415 | In distribution | |
| KR-53160 | In distribution | |
| KR-50150 | In distribution | |
| WS-40232 | In distribution | |
| KS-99110 | In distribution | |
| KR-54180 | In distribution | |
| XK704815 | In distribution | |
| KR-54170 | In distribution | |
| XK-67917 | In distribution | |
| WS-40051 | In distribution | |
| KR-51180 | In distribution | |
| KR-50180 | In distribution | |
| KR-50165-R | In distribution | |
| WS-40029 | In distribution | |
| KR-50125 | In distribution | |
| KR-52210 | In distribution | |
| KR-50115 | In distribution | |
| KS-67071 | In distribution | |
| WS-40065 | In distribution | |
| KS-99111 | In distribution | |
| KR-53110 | In distribution | |
| KR-53230 | In distribution | |
| KR-52170 | In distribution | |
| KR-52250 | In distribution | |
| KR-50215 | In distribution | |
| KS-99131 | In distribution | |
| KR-53170 | In distribution | |
| KS-99133 | In distribution | |
| KR-50260 | In distribution | |
| KR-50080 | In distribution | |
| KR-54240 | In distribution | |
| XK-72411 | In distribution | |
| KR-52160 | In distribution | |
| KR-54190 | 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 |
| 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 |
| Arthrex | Provision | 98 |
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.