Regatta Lateral System
Lateral Box Cutter, 4x18mm, Angled
17manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | FZT |
| Device type | Cutter, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2025-10-24 (version 5) |
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 | 2022-04-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95-6617 | 4x18mm | In distribution |
| 95-6615 | 4x18mm | In distribution |
| 95-6619 | 6x23mm | In distribution |
| 95-6618 | 4x23mm | In distribution |
| 95-6614 | 4x18mm | In distribution |
| 95-6616 | 6x18mm | In distribution |
| 95-6628 | 4x23mm | Withdrawn |
| 95-6629 | 6x23mm | Withdrawn |
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.