The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for The Ligament Anchor Soft Screw.
| Device ID | K994152 |
| 510k Number | K994152 |
| Device Name: | THE LIGAMENT ANCHOR SOFT SCREW |
| 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 | 1999-12-08 |
| Decision Date | 2000-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055343834718 | K994152 | 000 |
| 05055343834572 | K994152 | 000 |
| 05055343834589 | K994152 | 000 |
| 05055343834596 | K994152 | 000 |
| 05055343834602 | K994152 | 000 |
| 05055343834619 | K994152 | 000 |
| 05055343834626 | K994152 | 000 |
| 05055343834633 | K994152 | 000 |
| 05055343834640 | K994152 | 000 |
| 05055343834657 | K994152 | 000 |
| 05055343834664 | K994152 | 000 |
| 05055343834671 | K994152 | 000 |
| 05055343834688 | K994152 | 000 |
| 05055343834695 | K994152 | 000 |
| 05055343834701 | K994152 | 000 |
| 05055343834565 | K994152 | 000 |