SLR Bipolar
SLR BIPOLAR POLY INSERT 36-40mm X 22mm ID
14manufacturers in China registered for this device type
51catalogue 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 | Microport Orthopedics Inc., United States |
|---|---|
| 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 | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-14 |
| Record revised | 2020-09-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 38 to 65 mm; lumen/inner diameter 22 to 32 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17000064 | Outer Diameter 64 mm | In distribution |
| 3110285400 | Outer Diameter 54 mm | In distribution |
| 17003210 | Lumen/Inner Diameter 32 mm | In distribution |
| 17000050 | Outer Diameter 50 mm | In distribution |
| 17002802 | Lumen/Inner Diameter 28 mm | In distribution |
| 17000065 | Outer Diameter 65 mm | In distribution |
| 17002804 | Lumen/Inner Diameter 28 mm | In distribution |
| 17000049 | Outer Diameter 49 mm | In distribution |
| 3110284400 | Outer Diameter 44 mm | In distribution |
| 17000044 | Outer Diameter 44 mm | In distribution |
| 17000060 | Outer Diameter 60 mm | In distribution |
| 17000041 | Outer Diameter 41 mm | In distribution |
| 17000040 | Outer Diameter 40 mm | In distribution |
| 17000054 | Outer Diameter 54 mm | In distribution |
| 17000045 | Outer Diameter 45 mm | In distribution |
| 17002812 | Lumen/Inner Diameter 28 mm | In distribution |
| 17000047 | Outer Diameter 47 mm | In distribution |
| 17000053 | Outer Diameter 53 mm | In distribution |
| 17000058 | Outer Diameter 58 mm | In distribution |
| 17003212 | Lumen/Inner Diameter 32 mm | In distribution |
| 3110284900 | Outer Diameter 49 mm | In distribution |
| 17000062 | Outer Diameter 62 mm | In distribution |
| 17000043 | Outer Diameter 43 mm | In distribution |
| 17002602 | Lumen/Inner Diameter 26 mm | In distribution |
| 17003208 | Lumen/Inner Diameter 32 mm | In distribution |
| 3110285200 | Outer Diameter 52 mm | In distribution |
| 17000048 | Outer Diameter 48 mm | In distribution |
| 17002814 | Lumen/Inner Diameter 28 mm | In distribution |
| 17000046 | Outer Diameter 46 mm | In distribution |
| 17000042 | Outer Diameter 42 mm | In distribution |
| 17000059 | Outer Diameter 59 mm | In distribution |
| 17002810 | Lumen/Inner Diameter 28 mm | In distribution |
| 17000055 | Outer Diameter 55 mm | In distribution |
| 17000056 | Outer Diameter 56 mm | In distribution |
| 17000051 | Outer Diameter 51 mm | In distribution |
| 17000061 | Outer Diameter 61 mm | In distribution |
| 17002201 | Lumen/Inner Diameter 22 mm | In distribution |
| 17003206 | Lumen/Inner Diameter 32 mm | In distribution |
| 17003204 | Lumen/Inner Diameter 32 mm | In distribution |
| 17000038 | Outer Diameter 38 mm | In distribution |
| 3110284200 | Outer Diameter 42 mm | In distribution |
| 3110285100 | Outer Diameter 51 mm | In distribution |
| 3110284100 | Outer Diameter 41 mm | In distribution |
| 17003202 | Lumen/Inner Diameter 32 mm | In distribution |
| 17000039 | Outer Diameter 39 mm | In distribution |
| 3110285800 | Outer Diameter 58 mm | In distribution |
| 17000052 | Outer Diameter 52 mm | In distribution |
| 17002808 | Lumen/Inner Diameter 28 mm | In distribution |
| 17002806 | Lumen/Inner Diameter 28 mm | In distribution |
| 17000057 | Outer Diameter 57 mm | In distribution |
| 17000063 | Outer Diameter 63 mm | 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.