FDA 510(k)

Navigated Pedicle Access Kit

K-Number: K191012 · 2019-08-07

Decision Date2019-08-07

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Navigated Pedicle Access Kit is a medical device manufactured by Izi Medical Products, LLC. It received FDA 510(k) clearance on 2019-08-07 under approval number K191012. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navigated Pedicle Access Kit?

Navigated Pedicle Access Kit is a medical device that received FDA 510(k) clearance on 2019-08-07. It is manufactured by Izi Medical Products, LLC. The 510(k) number is K191012.

When was Navigated Pedicle Access Kit approved by the FDA?

Navigated Pedicle Access Kit received FDA 510(k) clearance on 2019-08-07, under approval number K191012.

What company makes Navigated Pedicle Access Kit?

Navigated Pedicle Access Kit is manufactured by Izi Medical Products, LLC.

What is the FDA product code for Navigated Pedicle Access Kit?

The FDA product code for Navigated Pedicle Access Kit is OLO.

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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.