The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Revival Modular Hip Stem.
| Device ID | K191374 |
| 510k Number | K191374 |
| Device Name: | Revival Modular Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Corin USA Limited 12750 Citrus Park Lane Tampa, FL 33625 |
| Contact | Rachel King |
| Correspondent | Rachel King Corin USA Limited 12750 Citrus Park Lane Tampa, FL 33625 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-23 |
| Decision Date | 2019-07-22 |
| Summary: | summary |