The following data is part of a premarket notification filed by Spineguard,s.a. with the FDA for Spineguard Dsg Zavation Screw System.
| Device ID | K162884 |
| 510k Number | K162884 |
| Device Name: | SpineGuard DSG Zavation Screw System |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | SPINEGUARD,S.A. 10 Cours Louis Lumiere Vincennes, FR 94300 |
| Contact | Stephane Bette |
| Correspondent | John J. Smith Hogan Lovells U.S. LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-14 |
| Decision Date | 2017-01-12 |
| Summary: | summary |