FDA 510(k)

SpineGuard DSG Zavation Screw System

K-Number: K162884 · 2017-01-12

Decision Date2017-01-12

Product CodeHBG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SpineGuard DSG Zavation Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Spineguard S.A.. It received FDA 510(k) clearance on 2017-01-12 under 510(k) 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. The listed applicant is Spineguard S.A.. The 510(k) number is K162884.

When did SpineGuard DSG Zavation Screw System receive FDA 510(k) clearance?

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

Who is the listed applicant for SpineGuard DSG Zavation Screw System?

The FDA 510(k) record lists Spineguard S.A. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Spineguard S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220160PediGuard Threaded K201454DSG Connect Technology K152747DSG Threaded Drill System

Related Devices (Code: HBG)

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

Official Source

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