The following data is part of a premarket notification filed by Corin Usa with the FDA for Cormet Cementless Resurfacing Femoral Head.
| Device ID | K092198 |
| 510k Number | K092198 |
| Device Name: | CORMET CEMENTLESS RESURFACING FEMORAL HEAD |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| 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 | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2010-04-15 |
| Summary: | summary |