SpineGuard DSG Zavation Screw System— 510(k) K162884

Name: FDA 510(k) clearance K162884
Creator: U.S. Food and Drug Administration
Published: 2017-01-12

Substantially Equivalent

Spineguard S.A.

FDA 510(k) clearance K162884 for SpineGuard DSG Zavation Screw System, Substantially Equivalent on 2017-01-12. Applicant: Spineguard S.A.. Device class: 2.

Clearance details

Applicant: Spineguard S.A.
Product code: Code HBG
Device class: Class 2
Regulation: 21 CFR 882.4300
Advisory panel: Neurology
Date received: 2016-10-14
Decision date: 2017-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vincennes, FR

Download summary PDF View on FDA.gov ↗

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