Rhead
Lateral Assembly, Radial Stem Implant, Collar 6mm, Size3
3manufacturers in China registered for this device type
46catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | JDB |
| Device type | Prosthesis, Elbow, Semi-Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3160 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2025-04-14 (version 11) |
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 |
| Distribution end date | 2024-04-16 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 310-0002 | In distribution | |
| 314-0103 | In distribution | |
| 314-0101 | In distribution | |
| 4100301 | In distribution | |
| 4100303 | In distribution | |
| 312-0507 | In distribution | |
| 310-0012 | In distribution | |
| 410-0100 | In distribution | |
| 312-0506 | In distribution | |
| 312-0706 | In distribution | |
| 312-0406 | In distribution | |
| 310-2020 | In distribution | |
| 313-0100 | In distribution | |
| 310-0004 | In distribution | |
| 310-0001 | In distribution | |
| 312-0606 | In distribution | |
| 410-0103 | In distribution | |
| 310-0011 | In distribution | |
| 310-0007 | In distribution | |
| 312-0707 | In distribution | |
| 410-0102 | In distribution | |
| 310-0013 | In distribution | |
| 310-0000 | In distribution | |
| 310-0003 | In distribution | |
| 310-2019 | In distribution | |
| 313-0101 | In distribution | |
| 4100300 | In distribution | |
| 313-0103 | In distribution | |
| 312-0607 | In distribution | |
| 310-0005 | In distribution | |
| 313-0102 | In distribution | |
| 314-0102 | In distribution | |
| 312-0407 | In distribution | |
| 4100302 | In distribution | |
| 726-0000 | In distribution | |
| 410-0101 | In distribution | |
| 310-2021 | In distribution | |
| 314-0104 | In distribution | |
| 600-0016 | Withdrawn | |
| 601-0116 | Withdrawn | |
| 310-0006 | Withdrawn | |
| 601-0110 | Withdrawn | |
| 100-0010 | Withdrawn | |
| 601-0009 | Withdrawn | |
| 601-0010 | Withdrawn | |
| 601-0111 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tema Elbow | Limacorporate | 90 |
| Latitude EV™ | Tornier Inc. | 33 |
| Latitude™ – Elbow | Tornier Inc. | 22 |
| UNI-Elbow | Stryker GmbH | 20 |
| Tema Elbow System | Limacorporate | 9 |
| Sorbie Questor ™ | Wright Medical Technology, Inc. | 9 |
| AMK | Depuy Orthopaedics, Inc. | 8 |
| RHS – Radial Prosthesis | Tornier Inc. | 7 |
| AML TRI-Lock | Depuy Orthopaedics, Inc. | 2 |
| Acclaim | Depuy Orthopaedics, Inc. | 2 |
| Elite | Depuy Intl., Ltd. | 1 |
| Latitude | Tornier Inc. | 1 |
Showing 12 of 18. All products under Prosthesis, Elbow, Semi-Constrained, 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.