K980496 is an FDA 510(k) clearance for the WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on April 14, 1998, 64 days after receiving the submission on February 9, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K980496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 09, 1998 |
| Decision Date | April 14, 1998 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | MNH — Orthosis, Spondylolisthesis Spinal Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |