The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Trifix Pedicle Spinal Screw Assembly.
| Device ID | K990657 |
| 510k Number | K990657 |
| Device Name: | TRIFIX PEDICLE SPINAL SCREW ASSEMBLY |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-03-26 |