Synovo HIP Components
HIP Acetabular Bearing - 52.5 MM I.D. X 66 TO 70 MM O.D.
13manufacturers in China registered for this device type
21catalogue 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 | Synovo Production |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Record published | 2024-03-04 |
| Record revised | 2024-03-14 (version 2) |
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 |
| Storage | Handling environment temperature 5 to 40 °C; Storage environment temperature 5 to 40 °C |
| Sizes | Outer diameter 46 to 70 mm; lumen/inner diameter 41 to 52.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-02-4760 | Outer Diameter 60 mm | In distribution |
| 01-02-4254 | Outer Diameter 54 mm | In distribution |
| 01-02-4456 | Outer Diameter 56 mm | In distribution |
| 01-01-0564 | Outer Diameter 64 mm | In distribution |
| 01-01-0570 | Outer Diameter 70 mm | In distribution |
| 01-01-0568 | 5 HOLE | In distribution |
| 01-02-4558 | Outer Diameter 58 mm | In distribution |
| 01-01-0550 | 5 HOLE | In distribution |
| 01-01-0560 | In distribution | |
| 01-02-5266 | Outer Diameter 66 mm | In distribution |
| 01-01-0558 | 5 HOLE | In distribution |
| 01-02-4152 | Outer Diameter 52 mm | In distribution |
| 01-02-4962 | Outer Diameter 62 mm | In distribution |
| 01-02-5164 | Lumen/Inner Diameter 51 mm | In distribution |
| 01-01-0566 | 5 HOLE | In distribution |
| 01-01-0548 | 5 HOLE | In distribution |
| 01-01-0554 | 5 HOLE | In distribution |
| 01-01-0552 | Outer Diameter 52 mm | In distribution |
| 01-01-0562 | 5 HOLE | In distribution |
| 01-01-0546 | Outer Diameter 46 mm | In distribution |
| 01-01-0556 | 5 HOLE | In distribution |
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.