FDA 510(k)

Joline Kyphoplasty System Allevo

K-Number: K192449 · 2020-05-27

Decision Date2020-05-27

Product CodeNDN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Joline Kyphoplasty System Allevo is a medical device manufactured by Joline GmbH & Co. KG. It received FDA 510(k) clearance on 2020-05-27 under approval number K192449. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Joline Kyphoplasty System Allevo?

Joline Kyphoplasty System Allevo is a medical device that received FDA 510(k) clearance on 2020-05-27. It is manufactured by Joline GmbH & Co. KG. The 510(k) number is K192449.

When was Joline Kyphoplasty System Allevo approved by the FDA?

Joline Kyphoplasty System Allevo received FDA 510(k) clearance on 2020-05-27, under approval number K192449.

What company makes Joline Kyphoplasty System Allevo?

Joline Kyphoplasty System Allevo is manufactured by Joline GmbH & Co. KG.

What is the FDA product code for Joline Kyphoplasty System Allevo?

The FDA product code for Joline Kyphoplasty System Allevo is NDN.

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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.