K133475 is an FDA 510(k) clearance for the STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on December 19, 2013, 37 days after receiving the submission on November 12, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K133475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2013 |
| Decision Date | December 19, 2013 |
| Days to Decision | 37 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWQ - Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |