FDA 510(k)

Auxein Brand Vertaux 5.5 mm Pedicle Screw System

Numéro K : K201457 · 2021-04-06

DemandeurAuxein Medical Private Limited/71164

Date de décision2021-04-06

Code produitNKB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Auxein Brand Vertaux 5.5 mm Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited/71164. It received FDA 510(k) clearance on 2021-04-06 under 510(k) number K201457. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Auxein Brand Vertaux 5.5 mm Pedicle Screw System?

Auxein Brand Vertaux 5.5 mm Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2021-04-06. The listed applicant is Auxein Medical Private Limited/71164. The 510(k) number is K201457.

When did Auxein Brand Vertaux 5.5 mm Pedicle Screw System receive FDA 510(k) clearance?

Auxein Brand Vertaux 5.5 mm Pedicle Screw System received FDA 510(k) clearance on 2021-04-06, under 510(k) number K201457.

Who is the listed applicant for Auxein Brand Vertaux 5.5 mm Pedicle Screw System?

The FDA 510(k) record lists Auxein Medical Private Limited/71164 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auxein Brand Vertaux 5.5 mm Pedicle Screw System?

The FDA product code for Auxein Brand Vertaux 5.5 mm Pedicle Screw System is NKB.

Essais cliniques associés

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Dispositifs connexes (Code : NKB)

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Source officielle

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