Vital Spinal Fixation System
Posterior Wall Osteotome 21 mm
9manufacturers in China registered for this device type
19catalogue 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 | Highridge Medical, LLC, 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 | 2025-12-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 732M3226 | Device Size Text, specify—Osteotome Impactor Left 26 mm | In distribution |
| 732M1208 | Device Size Text, specify—Stright Osteotome 8 mm | In distribution |
| 732M3221 | Device Size Text, specify—Osteotome Impactor Left 21 mm | In distribution |
| 732M1212 | Device Size Text, specify—Straight Osteotome 12 mm | In distribution |
| 732M1721 | Device Size Text, specify—Posterior Wall Osteotome 21 mm | In distribution |
| 732M1106 | Device Size Text, specify—Curved Osteotome 6 mm | In distribution |
| 732M1210 | Device Size Text, specify—Straight Osteotome 10 mm | In distribution |
| 732M1108 | Device Size Text, specify—Curved Osteotome 8 mm | In distribution |
| 732M0406 | Device Size Text, specify—90° Osteotome 6 x 6 mm | In distribution |
| 732M1724 | Device Size Text, specify—Posterior Wall Osteotome 24 mm | In distribution |
| 732M1110 | Device Size Text, specify—Curved Osteotome 10 mm | In distribution |
| 732M3126 | Device Size Text, specify—Osteotome Impactor Right 26 mm | In distribution |
| 732M1112 | Device Size Text, specify—Curved Osteotome 12 mm | In distribution |
| 732M3124 | Device Size Text, specify—Osteotome Impactor Right 24 mm | In distribution |
| 732M1726 | Device Size Text, specify—Posterior Wall Osteotome 26 mm | In distribution |
| 732M0408 | Device Size Text, specify—90° Osteotome 8 x 8 mm | In distribution |
| 732M1206 | Device Size Text, specify—Straight Osteotome 6 mm | In distribution |
| 732M0410 | Device Size Text, specify—90° Osteotome 10 x 10 mm | In distribution |
| 732M3121 | Device Size Text, specify—Osteotome Impactor Right 21 mm | 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.