FDA 510(k)

Zenius, Iliad and Kora Spinal Fixation Systems

K-Number: K181978 · 2018-08-13

Decision Date2018-08-13

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Zenius, Iliad and Kora Spinal Fixation Systems is a medical device manufactured by Medyssey USA, Inc.. It received FDA 510(k) clearance on 2018-08-13 under approval number K181978. 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, Iliad and Kora Spinal Fixation Systems?

Zenius, Iliad and Kora Spinal Fixation Systems is a medical device that received FDA 510(k) clearance on 2018-08-13. It is manufactured by Medyssey USA, Inc.. The 510(k) number is K181978.

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

Zenius, Iliad and Kora Spinal Fixation Systems received FDA 510(k) clearance on 2018-08-13, under approval number K181978.

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

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

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

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

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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.