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FDA 510(k)

SpineGuard DSG Zavation Screw System

K-Number: K162884 · 2017-01-12

ApplicantSpineguard S.A.
Decision Date2017-01-12
Product CodeHBG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SpineGuard DSG Zavation Screw System is a medical device manufactured by Spineguard S.A.. It received FDA 510(k) clearance on 2017-01-12 under approval number K162884. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpineGuard DSG Zavation Screw System?

SpineGuard DSG Zavation Screw System is a medical device that received FDA 510(k) clearance on 2017-01-12. It is manufactured by Spineguard S.A.. The 510(k) number is K162884.

When was SpineGuard DSG Zavation Screw System approved by the FDA?

SpineGuard DSG Zavation Screw System received FDA 510(k) clearance on 2017-01-12, under approval number K162884.

What company makes SpineGuard DSG Zavation Screw System?

SpineGuard DSG Zavation Screw System is manufactured by Spineguard S.A..

What is the FDA product code for SpineGuard DSG Zavation Screw System?

The FDA product code for SpineGuard DSG Zavation Screw System is HBG.

Related Clinical Trials

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Other Devices by Spineguard S.A.

K152747DSG Threaded Drill System K201454DSG Connect Technology K220160PediGuard Threaded

Related Devices (Code: HBG)

K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc. K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC K252696LEGACYPhasor Health, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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