9 catalogue numbers from 323.05.070, listed by Corin Limited, United Kingdom, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous. 5 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Corin Trinity™ Plus Acetabular Shell | Listed by | Corin Limited, United Kingdom |
| FDA product code | MBL |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172551 |
| Record published | 2018-08-21 |
| Record revised | 2020-09-09 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
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.