Osteotome
Osteotome-Straight 10MM 250MM LENGTH/230MM Handle
9manufacturers in China registered for this device type
39catalogue 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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HWM |
| Device type | Osteotome |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-10-12 |
| Record revised | 2022-05-02 (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 |
|---|---|---|
| 399.82 | In distribution | |
| 389.851 | In distribution | |
| 03.100.303 | In distribution | |
| SD03.100.315 | In distribution | |
| 03.100.307 | In distribution | |
| 399.81 | In distribution | |
| SD03.605.508 | In distribution | |
| 03.100.304 | In distribution | |
| SD389.575 | In distribution | |
| 03.100.301 | In distribution | |
| SD399.088 | In distribution | |
| SD389.576 | In distribution | |
| 389.574 | In distribution | |
| 03.605.009 | In distribution | |
| SD399.085 | In distribution | |
| SD03.100.310 | In distribution | |
| SD399.087 | In distribution | |
| SD399.017 | In distribution | |
| 389.852 | In distribution | |
| SD389.577 | In distribution | |
| 399.80 | In distribution | |
| SD03.100.038 | In distribution | |
| 389.276 | In distribution | |
| 389.74 | In distribution | |
| SD399.086 | In distribution | |
| 03.100.302 | In distribution | |
| 03.505.220 | In distribution | |
| 399.86 | In distribution | |
| 03.605.508 | In distribution | |
| 389.277 | In distribution | |
| 389.73 | In distribution | |
| 389.575 | In distribution | |
| 389.72 | In distribution | |
| 399.85 | In distribution | |
| 03.100.306 | In distribution | |
| 03.100.300 | In distribution | |
| 03.100.305 | In distribution | |
| 03.100.039 | In distribution | |
| 03.100.038 | 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.