Rhead
Lateral Assembly, Radial Stem Head Implant, Size 4
3manufacturers in China registered for this device type
53catalogue 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 | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2025-04-14 (version 9) |
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 |
|---|---|---|
| 310-0009 | In distribution | |
| 17-0946 | In distribution | |
| 310-2011 | In distribution | |
| RCN-S260 | In distribution | |
| 310-2015 | In distribution | |
| 17-1649 | In distribution | |
| RHA-S460 | In distribution | |
| 310-2013 | In distribution | |
| 312-0511 | In distribution | |
| RCN-S4 | In distribution | |
| 312-0711 | In distribution | |
| 17-0972 | In distribution | |
| 17-0950 | In distribution | |
| RHA-S160 | In distribution | |
| RHA-H4 | In distribution | |
| RHA-S3 | In distribution | |
| 310-2014 | In distribution | |
| 310-2024 | In distribution | |
| RHA-H3 | In distribution | |
| RCN-S160 | In distribution | |
| RCN-H4 | In distribution | |
| RHA-S360 | In distribution | |
| 601-0008 | In distribution | |
| RHA-H2 | In distribution | |
| 17-0947 | In distribution | |
| RCN-H2 | In distribution | |
| RHA-S2 | In distribution | |
| 310-2012 | In distribution | |
| 310-0008 | In distribution | |
| 17-0951 | In distribution | |
| RCN-S1 | In distribution | |
| 17-1650 | In distribution | |
| RCN-S3 | In distribution | |
| RCN-S360 | In distribution | |
| RHA-S1 | In distribution | |
| RHA-S4 | In distribution | |
| RCN-H3 | In distribution | |
| 310-2016 | In distribution | |
| 17-0948 | In distribution | |
| 310-2023 | In distribution | |
| 17-1651 | In distribution | |
| 310-2017 | In distribution | |
| RCN-S2 | In distribution | |
| 310-2018 | In distribution | |
| RCN-S460 | In distribution | |
| RHA-S260 | In distribution | |
| 310-2025 | In distribution | |
| 310-2022 | In distribution | |
| 310-2010 | In distribution | |
| 310-0010 | In distribution | |
| 17-0949 | In distribution | |
| 17-1652 | In distribution | |
| 312-0611 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 175 |
| Align | Skeletal Dynamics L.L.C. | 97 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes (U.S.A.) LP | 78 |
| Evolve | Wright Medical Technology, Inc. | 75 |
| L2L™ | Zimmer, Inc. | 48 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes Gmbh | 43 |
| Explor | Biomet Orthopedics | 32 |
| Avenger | IN2BONES USA, LLC | 32 |
| BioPoly® Radial Head Implant | Biopoly, LLC | 30 |
| Seitz Solution Radial Head | Kapp Surgical Instrument, Inc. | 27 |
| Integra® | Ascension Orthopedics, Inc. | 23 |
| Modular Radial Head (MRH) System | Smith & Nephew, Inc. | 22 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
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.