Ic-Bipolar Head CoCrMo
18 catalogue numbers from 21510048, listed by implantcast GmbH, Germany, under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
18catalogue numbers in this listing
1510(k) clearance
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 | implantcast GmbH, Germany |
|---|---|
| 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 | Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-10-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21510048 | Size: 28/48mm | In distribution |
| 21510050 | Size: 28/50mm | In distribution |
| 21510049 | Size: 28/49mm | In distribution |
| 21510044 | Size: 28/44mm | In distribution |
| 21510058 | Size: 28/58mm | In distribution |
| 21510056 | Size: 28/56mm | In distribution |
| 21510059 | Size: 28/59mm | In distribution |
| 21510052 | Size: 28/52mm | In distribution |
| 21510051 | Size: 28/51mm | In distribution |
| 21510055 | Size: 28/55mm | In distribution |
| 21510054 | Size: 28/54mm | In distribution |
| 21510057 | Size: 28/57mm | In distribution |
| 21510060 | Size: 28/60mm | In distribution |
| 21510046 | Size: 28/46mm | In distribution |
| 21510053 | Size: 28/53mm | In distribution |
| 21510047 | Size: 28/47mm | In distribution |
| 21510045 | Size: 28/45mm | In distribution |
| 21510062 | Size: 28/62mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191569 | 2019-08-28 |
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.