The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Corin Metafix Hip Stem.
| Device ID | K130634 |
| 510k Number | K130634 |
| Device Name: | CORIN METAFIX HIP STEM |
| 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 | Lucinda Gerber |
| Correspondent | Lucinda Gerber CORIN U.S.A. 5670 W CYPRESS STREET SUITE C Tampa, FL 33607 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-05-24 |
| Summary: | summary |