K162884 is an FDA 510(k) clearance for the SpineGuard DSG Zavation Screw System. This device is classified as a Drills, Burrs, Trephines & Accessories (manual) (Class II - Special Controls, product code HBG).
Submitted by Spineguard S.A. (Vincennes, FR). The FDA issued a Cleared decision on January 12, 2017, 90 days after receiving the submission on October 14, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4300.
| 510(k) Number | K162884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2016 |
| Decision Date | January 12, 2017 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBG - Drills, Burrs, Trephines & Accessories (manual) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4300 |