K990657 is an FDA 510(k) clearance for the TRIFIX PEDICLE SPINAL SCREW ASSEMBLY. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on March 26, 1999, 25 days after receiving the submission on March 1, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K990657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1999 |
| Decision Date | March 26, 1999 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | MNH - Orthosis, Spondylolisthesis Spinal Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |