SpineGuard DSG Zavation Screw System
FDA 510(k) K162884 · Spineguard S.A.
510(k) numberK162884
Submission
- Device name
- SpineGuard DSG Zavation Screw System
- Applicant
- Spineguard S.A.
Vincennes, FR - Received
- October 14, 2016
- Decision date
- January 12, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SpineGuard DSG Zavation Screw System cleared by the FDA?
SpineGuard DSG Zavation Screw System (K162884) received a 510(k) decision of Substantially Equivalent on January 12, 2017, 90 days after the submission was received.
What is the product code of K162884?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.