Tecomet
Hand Held Rod Cutter, 3.50-4.50-5.50-6.35 Cervical Collapsible/Removeable Stand Stainless Steel Ortho-Grip™, Midnight Blue
17manufacturers in China registered for this device type
89catalogue 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 | Tecomet, Inc., United States |
|---|---|
| FDA product code | FZT |
| Device type | Cutter, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-10-08 |
| Record revised | 2026-06-09 (version 4) |
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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RC401000-BK | In distribution | |
| RC305000-AF | In distribution | |
| RC404026-A | In distribution | |
| RC301002-A | In distribution | |
| RC404001-J | In distribution | |
| RC402000-E | In distribution | |
| RC514023-AD | In distribution | |
| RC701001-B | In distribution | |
| 808-528 | In distribution | |
| RC614023-AD | In distribution | |
| RC701001-J | In distribution | |
| 46626 | In distribution | |
| RC301000-A | In distribution | |
| RC402000-A | In distribution | |
| RC614025-BN | In distribution | |
| RC404027-A | In distribution | |
| RC404023-BJ | In distribution | |
| RC305003-A | In distribution | |
| 00480904500 | In distribution | |
| RC701000-J | In distribution | |
| RC701000-A | In distribution | |
| RC305009-J | In distribution | |
| RC302002-E | In distribution | |
| RC701005-A | In distribution | |
| RC404023-A | In distribution | |
| RC305005-A | In distribution | |
| RC301002-J | In distribution | |
| RC305008-AF | In distribution | |
| RC701003-J | In distribution | |
| 46633 | In distribution | |
| RC402002-A | In distribution | |
| RC305001-A | In distribution | |
| RC301004-BN | In distribution | |
| RC701002-J | In distribution | |
| RC302002-J | In distribution | |
| 46632 | In distribution | |
| RC404020-J | In distribution | |
| RC304001-J | In distribution | |
| RC701005-J | In distribution | |
| RC304007-J | In distribution | |
| 600-RC305003-BZ | In distribution | |
| RC701001-A | In distribution | |
| RC614026-A | In distribution | |
| RC404000-J | In distribution | |
| RC304008-M | In distribution | |
| KM46629 | In distribution | |
| RC402000-J | In distribution | |
| RC404000-AF | In distribution | |
| RC614025-J | In distribution | |
| RC404020-BI | In distribution | |
| RC514021-A | In distribution | |
| RC614024-J | In distribution | |
| RC301000-J | In distribution | |
| RC401000-A | In distribution | |
| 2167-10-000 | In distribution | |
| RC305006-A | In distribution | |
| RC305003-B | In distribution | |
| RC301003-A | In distribution | |
| RC701006-A | In distribution | |
| RC614024-A | In distribution | |
| RC305002-A | In distribution | |
| RC404030-J | In distribution | |
| RC404029-A | In distribution | |
| RC304000-J | In distribution | |
| KM46629 | In distribution | |
| RC404000-A | In distribution | |
| RC402010-AU | In distribution | |
| RC701001-E | In distribution | |
| 808-529 | In distribution | |
| RC402009-E | In distribution | |
| RC305003-BZ | In distribution | |
| RC404001-A | In distribution | |
| 46629 | In distribution | |
| RC304000-A | In distribution | |
| RC305004-J | In distribution | |
| RC304000-BJ | In distribution | |
| RC404014-A | In distribution | |
| RC404016-J | In distribution | |
| RC301004-J | In distribution | |
| RC701007-J | In distribution | |
| RC305004-A | In distribution | |
| RC301000-BN | In distribution | |
| RC701003-E | In distribution | |
| 2167-12-000 | In distribution | |
| RC404012-E | In distribution | |
| RC305002-B | In distribution | |
| RC404022-E | In distribution | |
| RC701000-BN | In distribution | |
| RC404001-AB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 326 |
| Sklar® | Sklar Corporation | 93 |
| 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 |
| Skyhawk | Orthofix US LLC | 19 |
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.