K081145 is an FDA 510(k) clearance for the MODIFICATION TO 4CIS VANE SPINE SYSTEM. This device is classified as a Orthosis, Spinal Pedicle Fixation (Class II - Special Controls, product code MNI).
Submitted by Solco Biomedical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on November 5, 2008, 197 days after receiving the submission on April 22, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K081145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2008 |
| Decision Date | November 05, 2008 |
| Days to Decision | 197 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNI - Orthosis, Spinal Pedicle Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |