FDA 510(k)

Zavation Spinal System

K-Number: K153404 · 2016-04-21

Decision Date2016-04-21

Product CodeMNH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Zavation Spinal System is a medical device manufactured by Zavation, LLC. It received FDA 510(k) clearance on 2016-04-21 under approval number K153404. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zavation Spinal System?

Zavation Spinal System is a medical device that received FDA 510(k) clearance on 2016-04-21. It is manufactured by Zavation, LLC. The 510(k) number is K153404.

When was Zavation Spinal System approved by the FDA?

Zavation Spinal System received FDA 510(k) clearance on 2016-04-21, under approval number K153404.

What company makes Zavation Spinal System?

Zavation Spinal System is manufactured by Zavation, LLC.

What is the FDA product code for Zavation Spinal System?

The FDA product code for Zavation Spinal System is MNH. This falls under the ENT category.

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Related PubMed Literature

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Related Devices (Code: MNH)

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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.