b-ONE™ Primary Acetabular System
Cementless Acetabular Shell, Cluster Hole; Porous Plasma Spray + HA Coating; 54mm Outer Diameter, Liner Size H
14manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | B-ONE Ortho, Corp., United States |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2019-03-11 |
| Record revised | 2020-12-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 881200361K | In distribution | |
| 881311541H | In distribution | |
| 881311601K | In distribution | |
| 881200361H | In distribution | |
| 881200281F | In distribution | |
| 881906146D | In distribution | |
| 881906144C | In distribution | |
| 881201361I | In distribution | |
| 881311621L | In distribution | |
| 881200321I | In distribution | |
| 881201281D | In distribution | |
| 881201321I | In distribution | |
| 881201281F | In distribution | |
| 881201321G | In distribution | |
| 881311641L | In distribution | |
| 881311441C | In distribution | |
| 881200361I | In distribution | |
| 881201281E | In distribution | |
| 881906158J | In distribution | |
| 881200321E | In distribution | |
| 881311461D | In distribution | |
| 881200281D | In distribution | |
| 881200361J | In distribution | |
| 881201361K | In distribution | |
| 881906156I | In distribution | |
| 881906150F | In distribution | |
| 881311561I | In distribution | |
| 881906152G | In distribution | |
| 881200321G | In distribution | |
| 881201361H | In distribution | |
| 881201281G | In distribution | |
| 881201361J | In distribution | |
| 881200361G | In distribution | |
| 881201321E | In distribution | |
| 881201321H | In distribution | |
| 881200281C | In distribution | |
| 881201361G | In distribution | |
| 881200281E | In distribution | |
| 881201321F | In distribution | |
| 881200361L | In distribution | |
| 881906164L | In distribution | |
| 881311581J | In distribution | |
| 881200321H | In distribution | |
| 881201281C | In distribution | |
| 881201361L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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.