The following data is part of a premarket notification filed by Corin Medical with the FDA for Trinity Acetabular System.
| Device ID | K130128 |
| 510k Number | K130128 |
| Device Name: | TRINITY ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CORIN MEDICAL 5670 W. CYPRESS STREET SUITE C Tampa, FL 33607 |
| Contact | Lucinda Gerber |
| Correspondent | Lucinda Gerber CORIN MEDICAL 5670 W. CYPRESS STREET SUITE C Tampa, FL 33607 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-17 |
| Decision Date | 2013-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055343870648 | K130128 | 000 |
| 05055343866467 | K130128 | 000 |
| 05055343866474 | K130128 | 000 |
| 05055343866481 | K130128 | 000 |
| 05055343866498 | K130128 | 000 |
| 05055343866504 | K130128 | 000 |
| 05055343866511 | K130128 | 000 |
| 05055343866528 | K130128 | 000 |
| 05055343866535 | K130128 | 000 |
| 05055343866542 | K130128 | 000 |
| 05055343866559 | K130128 | 000 |
| 05055343866566 | K130128 | 000 |
| 05055343866573 | K130128 | 000 |
| 05055343870624 | K130128 | 000 |
| 05055343870631 | K130128 | 000 |
| 05055343866450 | K130128 | 000 |