K980447 is an FDA 510(k) clearance for the DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 14, 1998, 68 days after receiving the submission on February 5, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K980447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 05, 1998 |
| Decision Date | April 14, 1998 |
| Days to Decision | 68 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 |