Corin BiPolar-i
BiPolar-i Instrument Tray
14manufacturers in China registered for this device type
54catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Record
| Listed by | Corin Limited, United Kingdom |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K183114 |
| Record published | 2019-07-25 |
| Record revised | 2022-09-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2110062 | In distribution | |
| 1110960 | In distribution | |
| 2110043 | In distribution | |
| 2110050 | In distribution | |
| 1110953 | In distribution | |
| 2110060 | In distribution | |
| 1110947 | In distribution | |
| 1110954 | In distribution | |
| 1110951 | In distribution | |
| 1110959 | In distribution | |
| 2110059 | In distribution | |
| 1110957 | In distribution | |
| 2110053 | In distribution | |
| 1110962 | In distribution | |
| 2110055 | In distribution | |
| 1110938 | In distribution | |
| 2110047 | In distribution | |
| 1110952 | In distribution | |
| 2110051 | In distribution | |
| 2110045 | In distribution | |
| 1110939 | In distribution | |
| 2110052 | In distribution | |
| 2110038 | In distribution | |
| 1110945 | In distribution | |
| 1110940 | In distribution | |
| 2110044 | In distribution | |
| 2110048 | In distribution | |
| 2110039 | In distribution | |
| 2110041 | In distribution | |
| 1110961 | In distribution | |
| 2110061 | In distribution | |
| 2110058 | In distribution | |
| 2110056 | In distribution | |
| 2110054 | In distribution | |
| 1110950 | In distribution | |
| 1110948 | In distribution | |
| 2110049 | In distribution | |
| 1110946 | In distribution | |
| S208.002 | In distribution | |
| 2110001 | In distribution | |
| 1110958 | In distribution | |
| 1110943 | In distribution | |
| 1110949 | In distribution | |
| 2110042 | In distribution | |
| 1110955 | In distribution | |
| 1110944 | In distribution | |
| 2119993 | In distribution | |
| 1110941 | In distribution | |
| 2119991 | In distribution | |
| 2110040 | In distribution | |
| 1110956 | In distribution | |
| 2110057 | In distribution | |
| 1110942 | In distribution | |
| 2110046 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 196 |
| Corin Bipolar Prosthesis | Corin Limited | 182 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 177 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 130 |
| Bencox Hip System | Corentec Co., Ltd. | 126 |
| United Hip System, U2 Bipolar Implant | United Orthopedic Corp. | 123 |
| MultiPolar® | Zimmer, Inc. | 100 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Zimmer, Inc. | 96 |
| Fitmore® Hip Stem | Zimmer, Inc. | 75 |
| Arcos® Modular Revision System | Biomet Orthopedics | 67 |
| Acumatch L-Series | Exactech, Inc. | 67 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
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.