UNI-Elbow
Axis Locator Clamp, Slot Position Bolt
3manufacturers in China registered for this device type
20catalogue 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 | 2016-09-24 |
| Record revised | 2025-04-14 (version 6) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 410-5060 | In distribution | |
| 410-3155 | In distribution | |
| 410-0008 | In distribution | |
| 410-5070 | In distribution | |
| 410-0000 | In distribution | |
| 410-5065 | In distribution | |
| 410-5050 | In distribution | |
| 410-0004 | In distribution | |
| 410-5045 | In distribution | |
| 410-0003 | In distribution | |
| 410-0002 | In distribution | |
| 410-0007 | In distribution | |
| 410-0009 | In distribution | |
| 410-5055 | In distribution | |
| 410-0006 | In distribution | |
| 410-3255 | In distribution | |
| 410-0001 | In distribution | |
| 410-3275 | In distribution | |
| 410-0005 | In distribution | |
| 410-3175 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tema Elbow | Limacorporate | 90 |
| Rhead | Stryker GmbH | 46 |
| Latitude EV™ | Tornier Inc. | 33 |
| Latitude™ – Elbow | Tornier Inc. | 22 |
| 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.