The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for The Corifix Ligament Anchor.
| Device ID | K973005 |
| 510k Number | K973005 |
| Device Name: | THE CORIFIX LIGAMENT ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Craig Corrance |
| Correspondent | Craig Corrance CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-13 |
| Decision Date | 1997-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055343880203 | K973005 | 000 |
| 05055196986756 | K973005 | 000 |
| 05055196986763 | K973005 | 000 |
| 05055196986770 | K973005 | 000 |
| 05055196986787 | K973005 | 000 |
| 05055196986794 | K973005 | 000 |
| 05055196986800 | K973005 | 000 |
| 05055196986817 | K973005 | 000 |
| 05055196986824 | K973005 | 000 |
| 05055196986831 | K973005 | 000 |
| 05055196994485 | K973005 | 000 |
| 05055196994492 | K973005 | 000 |
| 05055196994508 | K973005 | 000 |
| 05055196994515 | K973005 | 000 |
| 05055196994539 | K973005 | 000 |
| 05055196994546 | K973005 | 000 |
| 05055196986749 | K973005 | 000 |