Submission Details
| 510(k) Number | K162884 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
SpineGuard DSG Zavation Screw System
Jan 2017
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K162884 is an FDA 510(k) clearance for the SpineGuard DSG Zavation Screw System, 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 review panel. Regulated under 21 CFR 882.4300.
Device Classification
| Product Code | HBG — Drills, Burrs, Trephines & Accessories (manual) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4300 |
Manufacturer
Similar Devices — HBG Drills, Burrs, Trephines & Accessories (manual)
All 16
K252696 · Phasor Health, LLC
· Nov 2025
K153587 · Synthes USA Products, LLC
· Jan 2017
K160129 · Mri Interventions, Inc.
· Mar 2016
K151536 · Mri Interventions, Inc.
· Jul 2015
K122456 · Mri Interventions, Inc.
· Mar 2013
K022712 · Medical Design, LLC
· Nov 2002
More from Spineguard S.A.
View all
K220160
· PDQ · Mar 2022
K201454
· PDQ · Feb 2021
K152747
· PDQ · Jun 2016
K143159
· PDQ · Jan 2015
K123390
· PDQ · Aug 2013