K943827 is an FDA 510(k) clearance for the SPINE FIXATION. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on February 14, 1996, 558 days after receiving the submission on August 5, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K943827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | August 05, 1994 |
| Decision Date | February 14, 1996 |
| Days to Decision | 558 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 |