C-Stem
C-STEM AMT Cemented Stem Standard Offset Size 2 LONG 12/14 TAPER
13manufacturers in China registered for this device type
36catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), 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 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K982918 |
| Record published | 2015-09-24 |
| Record revised | 2024-12-13 (version 8) |
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 |
| Distribution end date | 2022-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1570-24-086 | In distribution | |
| 9612-14-500 | In distribution | |
| 1570-14-150 | In distribution | |
| 1570-24-087 | In distribution | |
| 1570-14-120 | In distribution | |
| 9612-46-000 | In distribution | |
| 1570-04-120 | In distribution | |
| 1570-24-085 | In distribution | |
| 1570-14-085 | In distribution | |
| 9612-12-500 | In distribution | |
| 1570-24-093 | In distribution | |
| 1570-14-110 | In distribution | |
| 1570-14-090 | In distribution | |
| 9612-10-500 | In distribution | |
| 9612-18-500 | In distribution | |
| 9612-16-500 | In distribution | |
| 1570-24-091 | In distribution | |
| 9613-07-000 | Withdrawn | |
| 9611-64-000 | Withdrawn | |
| 9613-09-000 | Withdrawn | |
| 9613-15-000 | Withdrawn | |
| 9611-60-000 | Withdrawn | |
| 9611-67-000 | Withdrawn | |
| 9613-08-000 | Withdrawn | |
| 9611-70-000 | Withdrawn | |
| 9613-11-000 | Withdrawn | |
| 9611-65-000 | Withdrawn | |
| 9611-63-000 | Withdrawn | |
| 9611-72-000 | Withdrawn | |
| 9611-74-000 | Withdrawn | |
| 9613-10-000 | Withdrawn | |
| 9611-66-000 | Withdrawn | |
| 9613-12-000 | Withdrawn | |
| 9611-62-000 | Withdrawn | |
| 9611-68-000 | Withdrawn | |
| 9611-61-000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.