The following data is part of a premarket notification filed by Corin Usa with the FDA for Revival(tm) Modular Revision Hip Stem.
| Device ID | K152903 |
| 510k Number | K152903 |
| Device Name: | REVIVAL(TM) Modular Revision Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CORIN USA 5670 W CYPRESS STREET Tampa, FL 33607 |
| Contact | Diana L. Nader-martone |
| Correspondent | Diana L. Nader-martone CORIN USA 5670 W CYPRESS STREET 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 | 2015-10-01 |
| Decision Date | 2016-04-29 |
| Summary: | summary |