Osteotome
Lambotte Mini Osteotome; 5"(12.5CM), Straight 6MM(1/4") TIP
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 | Black & Black Surgical, Inc., United States |
|---|---|
| FDA product code | HWM |
| Device type | Osteotome |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-21 |
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 |
|---|---|---|
| B64005 | In distribution | |
| B64060 | In distribution | |
| B64050 | In distribution | |
| B64056 | In distribution | |
| B64105 | In distribution | |
| B64083 | In distribution | |
| B64017 | In distribution | |
| B64012 | In distribution | |
| B64015 | In distribution | |
| B64025 | In distribution | |
| B64024 | In distribution | |
| B64033 | In distribution | |
| B64052 | In distribution | |
| B64021 | In distribution | |
| B64035 | In distribution | |
| B64075 | In distribution | |
| B64103 | In distribution | |
| B64036 | In distribution | |
| B64106 | In distribution | |
| B64031 | In distribution | |
| B64102 | In distribution | |
| B64028 | In distribution | |
| B64027 | In distribution | |
| B64006 | In distribution | |
| B64070 | In distribution | |
| B64057 | In distribution | |
| B64016 | In distribution | |
| B64032 | In distribution | |
| B64019 | In distribution | |
| B64026 | In distribution | |
| B64034 | In distribution | |
| B64018 | In distribution | |
| B64051 | In distribution | |
| B64071 | In distribution | |
| B64020 | In distribution | |
| B64022 | In distribution | |
| B64013 | In distribution | |
| B64059 | In distribution | |
| B64104 | In distribution | |
| B64010 | In distribution | |
| B64014 | In distribution | |
| B64030 | In distribution | |
| B64100 | In distribution | |
| B64023 | In distribution | |
| B64053 | In distribution | |
| B64011 | In distribution | |
| B64101 | 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.