K053581 is an FDA 510(k) clearance for the NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on February 17, 2006, 56 days after receiving the submission on December 23, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K053581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2005 |
| Decision Date | February 17, 2006 |
| Days to Decision | 56 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 |