K143377 is an FDA 510(k) clearance for the PedFuse Pedicle Screw System. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on February 12, 2015, 79 days after receiving the submission on November 25, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K143377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2014 |
| Decision Date | February 12, 2015 |
| Days to Decision | 79 days |
| Submission Type | Special |
| 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 |