The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Metafix Femoral Stem.
| Device ID | K082525 |
| 510k Number | K082525 |
| Device Name: | CORIN METAFIX FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612 |
| Contact | Ashlea Bowen |
| Correspondent | Ashlea Bowen CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2010-02-04 |
| Summary: | summary |