Vail OCT Spinal Fixation System
KM 46-629 Rod Cutter 4 mm
17manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (3), Zhejiang (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Ningbo Huakun Medical Equipment Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 19 |
Showing 12 of 17. All 17 manufacturers in China registered for Cutter, Surgical
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | FZT |
| Device type | Cutter, Surgical |
| 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 |
|---|---|---|
| 7900-3500-049 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 326 |
| Sklar® | Sklar Corporation | 93 |
| Tecomet | Tecomet, Inc. | 89 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 46 |
| Aesculap | Aesculap AG | 38 |
| Orthomed | Ortho-MED, Inc. | 37 |
| Surtex | Surtex Instruments Ltd | 35 |
| SeaSpine Spacer System – Pacifica | Seaspine Orthopedics Corporation | 24 |
| Millennium | Avalign Technologies, Inc. | 23 |
| Cutter, Surgical | Medtronic Sofamor Danek, Inc. | 22 |
| Medtronic Resuable Instruments | Medtronic Sofamor Danek, Inc. | 22 |
| Velofix™ PEEK Lumbar Cage | CG MedTech Co., Ltd. | 20 |
Showing 12 of 177. All products under Cutter, Surgical
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.