The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Corin Trinity Acetabular System With Extra-long Heads.
| Device ID | K130343 |
| 510k Number | K130343 |
| Device Name: | CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CORIN U.S.A. 5670 W CYPRESS STREET SUITE C Tampa, FL 33607 |
| Contact | Diana L Martone |
| Correspondent | Diana L Martone CORIN U.S.A. 5670 W CYPRESS STREET 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 | 2013-02-11 |
| Decision Date | 2013-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055196968349 | K130343 | 000 |
| 05055196968332 | K130343 | 000 |
| 05055196937956 | K130343 | 000 |
| 05055196937918 | K130343 | 000 |
| 05055196937123 | K130343 | 000 |
| 05055196926998 | K130343 | 000 |