The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Corin Metafix™ Hip Stem.
| Device ID | K212069 |
| 510k Number | K212069 |
| Device Name: | Corin MetaFix™ Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Corin USA Limited 5670 W. Cypress St., Suite C Tampa, FL 33607 |
| Contact | Janet Grannells |
| Correspondent | Janet Grannells Corin USA Limited 5670 W. Cypress St., Suite C Tampa, FL 33607 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | MEH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-02 |
| Decision Date | 2022-04-07 |