The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Trinity-i Acetabular Shell.
| Device ID | K122305 |
| 510k Number | K122305 |
| Device Name: | CORIN TRINITY-I ACETABULAR SHELL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612 |
| Contact | Diana L Martone |
| Correspondent | Diana L Martone CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2012-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055343871157 | K122305 | 000 |
| 05055343871140 | K122305 | 000 |
| 05055343871133 | K122305 | 000 |
| 05055343870617 | K122305 | 000 |
| 05055343870600 | K122305 | 000 |
| 05055343870594 | K122305 | 000 |