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FDA 510(k)

Zavation eZspand Interbody System

K-Number: K191339 · 2019-08-19

ApplicantZavation Medical Products, LLC
Decision Date2019-08-19
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zavation eZspand Interbody System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2019-08-19 under approval number K191339. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zavation eZspand Interbody System?

Zavation eZspand Interbody System is a medical device that received FDA 510(k) clearance on 2019-08-19. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K191339.

When was Zavation eZspand Interbody System approved by the FDA?

Zavation eZspand Interbody System received FDA 510(k) clearance on 2019-08-19, under approval number K191339.

What company makes Zavation eZspand Interbody System?

Zavation eZspand Interbody System is manufactured by Zavation Medical Products, LLC.

What is the FDA product code for Zavation eZspand Interbody System?

The FDA product code for Zavation eZspand Interbody System is MAX.

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Related Devices (Code: MAX)

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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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