Medtronic Reusable Instruments
lNSTRUMENT 778000018 STRT OSTEOTOME 6.35
9manufacturers in China registered for this device type
47catalogue 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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | HWM |
| Device type | Osteotome |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-10-08 |
| Record revised | 2025-11-11 (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 |
| Distribution end date | 2026-04-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0211199 | In distribution | |
| EX0618087 | In distribution | |
| EX0610052 | In distribution | |
| X0196-041 | In distribution | |
| EX0211202 | In distribution | |
| EX0211199 | In distribution | |
| 9198120 | In distribution | |
| EX0222040 | In distribution | |
| EX0810747 | In distribution | |
| EX1210161 | In distribution | |
| 778000018 | In distribution | |
| EX0913038 | In distribution | |
| EX0112140 | In distribution | |
| EX0222041 | In distribution | |
| EX1110252 | In distribution | |
| X0196-042 | In distribution | |
| EX0720035 | In distribution | |
| EX1111583 | In distribution | |
| EX0725010 | In distribution | |
| 778000019 | In distribution | |
| X0102009 | In distribution | |
| X0703063 | In distribution | |
| EX0312047 | In distribution | |
| EX09103791 | In distribution | |
| EX0112139 | In distribution | |
| EX1225002 | In distribution | |
| EX0811303 | In distribution | |
| EX0312048 | In distribution | |
| X0102010 | In distribution | |
| EX0618086 | In distribution | |
| EX0126006 | In distribution | |
| 778000010 | In distribution | |
| X1110252 | In distribution | |
| EX0720036 | In distribution | |
| EX0618089 | In distribution | |
| EX0618088 | In distribution | |
| EX0610051 | In distribution | |
| X0703062 | In distribution | |
| EX09103770 | In distribution | |
| EX0720037 | In distribution | |
| EX0813042 | In distribution | |
| X0410082 | Withdrawn | |
| X0501007 | Withdrawn | |
| X807-922 | Withdrawn | |
| X1000008 | Withdrawn | |
| X0501006 | Withdrawn | |
| X807-923 | Withdrawn |
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.