Kincise
KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ SUMMIT™ Stem Impactor- Straight
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Guangdong (3). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HWE |
| Device type | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-10-25 |
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, serial number |
| Storage | Storage environment temperature -29 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 200002203 | In distribution | |
| 200007008 | In distribution | |
| 2000-00-101 | In distribution | |
| 200003201 | In distribution | |
| 200002100 | In distribution | |
| 200002002 | In distribution | |
| 200002102 | In distribution | |
| 200002212 | In distribution | |
| 200002202 | In distribution | |
| 2000-00-001 | In distribution | |
| 200002003 | In distribution | |
| 200004012 | In distribution | |
| 200003001 | In distribution | |
| 200002213 | In distribution | |
| 200002012 | In distribution | |
| 200003002 | In distribution | |
| 200003012 | In distribution | |
| 200003202 | In distribution | |
| 200002101 | In distribution | |
| 200002301 | In distribution | |
| 2000-00-201 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EZX | Imedicom Co., Ltd. | 441 |
| Arthrex® | Arthrex, Inc. | 391 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Stryker GmbH | 284 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 231 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Synthes Gmbh | 226 |
| Brasseler EZX | Imedicom Co., Ltd. | 187 |
| Conserve® | Microport Orthopedics Inc. | 158 |
| R3 | Smith & Nephew, Inc. | 147 |
| Trigen | Smith & Nephew, Inc. | 139 |
| MicroPort | Microport Orthopedics Inc. | 134 |
| Made-To-Order | Tornier Inc. | 131 |
| Profemur® | Microport Orthopedics Inc. | 129 |
Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-12-19 | Class II | Process design | In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged. | 249 | 2016-05-19 |
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.