Avalign
French Pattern Osteotome, mushroom head, OL 150mm (6"), TW 7mm(1/4")
9manufacturers in China registered for this device type
86catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (2), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | HWM |
| Device type | Osteotome |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-03 |
| Record revised | 2023-07-06 (version 2) |
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 |
|---|---|---|
| VM104-1261 | In distribution | |
| VM104-1201 | In distribution | |
| VM81-4805 | In distribution | |
| VM104-1226 | In distribution | |
| VM104-1283 | In distribution | |
| VM104-1207 | In distribution | |
| VM104-1203 | In distribution | |
| VM81-4890 | In distribution | |
| VM104-1272 | In distribution | |
| VM81-4893 | In distribution | |
| VM104-1143 | In distribution | |
| VM104-1363 | In distribution | |
| VM104-1165 | In distribution | |
| VM107-6753 | In distribution | |
| VM104-1100 | In distribution | |
| VM81-4889 | In distribution | |
| VM104-1297 | In distribution | |
| VM104-11491 | In distribution | |
| VM104-1361 | In distribution | |
| VM104-1145 | In distribution | |
| VM104-1183 | In distribution | |
| VM104-1197 | In distribution | |
| VM104-1915 | In distribution | |
| VM104-1185 | In distribution | |
| VM104-1155 | In distribution | |
| VM104-1146 | In distribution | |
| VM104-1187 | In distribution | |
| VM104-1140 | In distribution | |
| VM104-1141 | In distribution | |
| VM104-1914 | In distribution | |
| VM104-1237 | In distribution | |
| VM104-1271 | In distribution | |
| VM104-1108 | In distribution | |
| VM107-6755 | In distribution | |
| VM81-4891 | In distribution | |
| VM104-1154 | In distribution | |
| VM104-1144 | In distribution | |
| VM104-1101 | In distribution | |
| VM81-4802 | In distribution | |
| VM104-1296 | In distribution | |
| VM81-4899 | In distribution | |
| VM104-1266 | In distribution | |
| VM104-1163 | In distribution | |
| VM104-1191 | In distribution | |
| VM104-1917 | In distribution | |
| VM107-6761 | In distribution | |
| VM104-1916 | In distribution | |
| VM104-1273 | In distribution | |
| VM104-1217 | In distribution | |
| VM81-4807 | In distribution | |
| VM104-1910 | In distribution | |
| VM81-4876 | In distribution | |
| VM81-4801 | In distribution | |
| VM81-4895 | In distribution | |
| VM104-1281 | In distribution | |
| VM81-4806 | In distribution | |
| VM81-4892 | In distribution | |
| VM104-1918 | In distribution | |
| VM104-1164 | In distribution | |
| VM104-1256 | In distribution | |
| VM104-1257 | In distribution | |
| VM107-6757 | In distribution | |
| VM104-1216 | In distribution | |
| VM104-1142 | In distribution | |
| VM104-1193 | In distribution | |
| VM104-1919 | In distribution | |
| VM81-480816 | In distribution | |
| VM107-6751 | In distribution | |
| VM81-4880 | In distribution | |
| VM81-4894 | In distribution | |
| VM104-1149 | In distribution | |
| VM104-1298 | In distribution | |
| VM81-4804 | In distribution | |
| VM81-4896 | In distribution | |
| VM104-1290 | In distribution | |
| VM104-1221 | In distribution | |
| VM81-4897 | In distribution | |
| VM104-1189 | In distribution | |
| VM104-1151 | In distribution | |
| VM104-1181 | In distribution | |
| VM104-1913 | In distribution | |
| VM104-1195 | In distribution | |
| VM81-4769 | In distribution | |
| VM104-1106 | In distribution | |
| VM104-1212 | In distribution | |
| VM107-6723 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 300 |
| Life Instruments | Life Instrument Corp. | 283 |
| Osteotome | KLS-Martin L.P. | 262 |
| Boss Instruments | Boss Instruments, Ltd. | 249 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 243 |
| Innomed, Inc. | Innomed, Inc. | 241 |
| Ambler Surgical | Ambler Surgical, LLC | 226 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 225 |
| Novo Surgical | Novo Surgical, Inc. | 213 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 177 |
| Osteotome | Biomet Microfixation | 170 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 158 |
Showing 12 of 279. All products under Osteotome
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.