The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Corin Trifit Ts Hip.
| Device ID | K153772 |
| 510k Number | K153772 |
| Device Name: | Corin TriFit TS Hip |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | CORIN USA LIMITED 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
| Contact | Diana L. Nader-martone |
| Correspondent | Diana L. Nader-martone CORIN USA LIMITED 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
| Product Code | MEH |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-31 |
| Decision Date | 2016-03-31 |