K043578 is an FDA 510(k) clearance for the THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Solco Biomedical Co., Ltd. (Bethesda, US). The FDA issued a Cleared decision on March 7, 2005, 69 days after receiving the submission on December 28, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K043578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2004 |
| Decision Date | March 07, 2005 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNH - Orthosis, Spondylolisthesis Spinal Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |