FDA 510(k)

Zenius, lliad and Kora Spinal Fixation Systems

K-Number: K171526 · 2017-08-21

Decision Date2017-08-21

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Zenius, lliad and Kora Spinal Fixation Systems is a medical device manufactured by Medyssey USA, Inc.. It received FDA 510(k) clearance on 2017-08-21 under approval number K171526. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zenius, lliad and Kora Spinal Fixation Systems?

Zenius, lliad and Kora Spinal Fixation Systems is a medical device that received FDA 510(k) clearance on 2017-08-21. It is manufactured by Medyssey USA, Inc.. The 510(k) number is K171526.

When was Zenius, lliad and Kora Spinal Fixation Systems approved by the FDA?

Zenius, lliad and Kora Spinal Fixation Systems received FDA 510(k) clearance on 2017-08-21, under approval number K171526.

What company makes Zenius, lliad and Kora Spinal Fixation Systems?

Zenius, lliad and Kora Spinal Fixation Systems is manufactured by Medyssey USA, Inc..

What is the FDA product code for Zenius, lliad and Kora Spinal Fixation Systems?

The FDA product code for Zenius, lliad and Kora Spinal Fixation Systems is NKB.

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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.