Gladiator® Bipolar
Gladiator® Bipolar 36MM OD X 22MM ID
14manufacturers in China registered for this device type
30catalogue 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 | 2015-10-20 |
| Record revised | 2020-09-09 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 36 to 65 mm; lumen/inner diameter 22 to 36 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GLBP2236 | Outer Diameter 36 mm | In distribution |
| GLBP3652 | Lumen/Inner Diameter 36 mm | In distribution |
| GLBP2842 | Outer Diameter 42 mm | In distribution |
| GLBP2843 | Lumen/Inner Diameter 28 mm | In distribution |
| GLBP3246 | Outer Diameter 46 mm | In distribution |
| GLBP2239 | Outer Diameter 39 mm | In distribution |
| GLBP3660 | Lumen/Inner Diameter 36 mm | In distribution |
| GLBP3663 | Outer Diameter 63 mm | In distribution |
| GLBP2241 | Lumen/Inner Diameter 22 mm | In distribution |
| GLBP2237 | Lumen/Inner Diameter 22 mm | In distribution |
| GLBP3657 | Outer Diameter 57 mm | In distribution |
| GLBP3248 | Outer Diameter 48 mm | In distribution |
| GLBP2844 | Outer Diameter 44 mm | In distribution |
| GLBP3654 | Lumen/Inner Diameter 36 mm | In distribution |
| GLBP2240 | Outer Diameter 40 mm | In distribution |
| GLBP3247 | Lumen/Inner Diameter 32 mm | In distribution |
| GLBP3658 | Lumen/Inner Diameter 36 mm | In distribution |
| GLBP3656 | Lumen/Inner Diameter 36 mm | In distribution |
| GLBP3651 | Outer Diameter 51 mm | In distribution |
| GLBP2845 | Lumen/Inner Diameter 28 mm | In distribution |
| GLBP3655 | Outer Diameter 55 mm | In distribution |
| GLBP3664 | Lumen/Inner Diameter 36 mm | In distribution |
| GLBP3249 | Outer Diameter 49 mm | In distribution |
| GLBP3659 | Outer Diameter 59 mm | In distribution |
| GLBP3653 | Outer Diameter 53 mm | In distribution |
| GLBP2238 | Outer Diameter 38 mm | In distribution |
| GLBP3661 | Outer Diameter 61 mm | In distribution |
| GLBP3662 | Lumen/Inner Diameter 36 mm | In distribution |
| GLBP3665 | Outer Diameter 65 mm | In distribution |
| GLBP3650 | Lumen/Inner Diameter 36 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.