HEX Drive Atraumatic RMR
43 catalogue numbers from SSI003260, listed by Zimmer, Inc., United States, under Reamer. 23 manufacturers in China are registered for this product code.
23manufacturers in China registered for this device type
43catalogue numbers in this listing
1510(k) clearance
1recall
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 | Zimmer, Inc., United States |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-08 |
| Record revised | 2023-05-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSI003260 | Size 53 | In distribution |
| SSI003255 | Size 48 | In distribution |
| SSI003246 | Size 39 | In distribution |
| SSI003252 | Size 45 | In distribution |
| SSI003268 | Size 61 | In distribution |
| SSI003281 | Size 74 | In distribution |
| SSI003278 | Size 71 | In distribution |
| SSI003265 | Size 58 | In distribution |
| SSI003283 | Size 76 | In distribution |
| SSI003282 | Size 75 | In distribution |
| SSI003272 | Size 65 | In distribution |
| SSI003256 | Size 49 | In distribution |
| SSI003284 | Size 77 | In distribution |
| SSI003261 | Size 54 | In distribution |
| SSI003285 | Size 78 | In distribution |
| SSI003249 | Size 42 | In distribution |
| SSI003271 | Size 64 | In distribution |
| SSI003247 | Size 40 | In distribution |
| SSI003287 | Size 80 | In distribution |
| SSI003286 | Size 79 | In distribution |
| SSI003250 | Size 43 | In distribution |
| SSI003262 | Size 55 | In distribution |
| SSI003264 | Size 57 | In distribution |
| SSI003267 | Size 60 | In distribution |
| SSI003273 | Size 66 | In distribution |
| SSI003276 | Size 69 | In distribution |
| SSI003259 | Size 52 | In distribution |
| SSI003257 | Size 50 | In distribution |
| SSI003266 | Size 59 | In distribution |
| SSI003279 | Size 72 | In distribution |
| SSI003263 | Size 56 | In distribution |
| SSI003274 | Size 67 | In distribution |
| SSI003275 | Size 68 | In distribution |
| SSI003254 | Size 47 | In distribution |
| SSI003253 | Size 46 | In distribution |
| SSI003258 | Size 51 | In distribution |
| SSI003280 | Size 73 | In distribution |
| SSI003277 | Size 70 | In distribution |
| SSI003248 | Size 41 | In distribution |
| SSI003269 | Size 62 | In distribution |
| SSI003245 | Size 38 | In distribution |
| SSI003270 | Size 63 | In distribution |
| SSI003251 | Size 44 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K954915 | 1995-12-28 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-12-07 | Class II | Process control | Two planers were found to be unusable during sawbones shoulder training. | 84 units |
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.