The following data is part of a premarket notification filed by Corin Usa with the FDA for Trinity Acetabular System.
| Device ID | K131647 |
| 510k Number | K131647 |
| Device Name: | TRINITY ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
| Contact | Diana L Martone |
| Correspondent | Diana L Martone CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-05 |
| Decision Date | 2013-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055343885123 | K131647 | 000 |
| 05055343885116 | K131647 | 000 |
| 05055343885109 | K131647 | 000 |
| 05055343885093 | K131647 | 000 |
| 05055343885086 | K131647 | 000 |