FDA 510(k)

Joline Kyphoplasty System Allevo

Numéro K : K192449 · 2020-05-27

Date de décision2020-05-27

Code produitNDN

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Joline GmbH & Co. KG. The 510(k) number is K192449.

When did Joline Kyphoplasty System Allevo receive FDA 510(k) clearance?

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

Who is the listed applicant for Joline Kyphoplasty System Allevo?

The FDA 510(k) record lists Joline GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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

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

Essais cliniques associés

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Source officielle

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