The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Unipolar Modular Head.
| Device ID | K063791 |
| 510k Number | K063791 |
| Device Name: | CORIN UNIPOLAR MODULAR HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612 |
| Contact | Kathy K Trier |
| Correspondent | Kathy K Trier CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055343839973 | K063791 | 000 |
| 05055343839782 | K063791 | 000 |
| 05055343839775 | K063791 | 000 |
| 05055343839768 | K063791 | 000 |
| 05055343839751 | K063791 | 000 |
| 05055343839744 | K063791 | 000 |
| 05055343839737 | K063791 | 000 |
| 05055343839720 | K063791 | 000 |
| 05055343839713 | K063791 | 000 |
| 05055343839706 | K063791 | 000 |
| 05055343839690 | K063791 | 000 |
| 05055343839683 | K063791 | 000 |
| 05055343839676 | K063791 | 000 |
| 05055343839669 | K063791 | 000 |
| 05055343839652 | K063791 | 000 |
| 05055343839645 | K063791 | 000 |
| 05055343839638 | K063791 | 000 |
| 05055343839799 | K063791 | 000 |
| 05055343839805 | K063791 | 000 |
| 05055343839966 | K063791 | 000 |
| 05055343839959 | K063791 | 000 |
| 05055343839942 | K063791 | 000 |
| 05055343839935 | K063791 | 000 |
| 05055343839928 | K063791 | 000 |
| 05055343839911 | K063791 | 000 |
| 05055343839904 | K063791 | 000 |
| 05055343839898 | K063791 | 000 |
| 05055343839881 | K063791 | 000 |
| 05055343839874 | K063791 | 000 |
| 05055343839867 | K063791 | 000 |
| 05055343839850 | K063791 | 000 |
| 05055343839843 | K063791 | 000 |
| 05055343839836 | K063791 | 000 |
| 05055343839829 | K063791 | 000 |
| 05055343839812 | K063791 | 000 |
| 05055343839621 | K063791 | 000 |