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FDA 510(k)

Auxein Brand Vertaux 5.5 mm Pedicle Screw System

K-Number: K201457 · 2021-04-06

ApplicantAuxein Medical Private Limited/71164
Decision Date2021-04-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

When was Auxein Brand Vertaux 5.5 mm Pedicle Screw System approved by the FDA?

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

What company makes Auxein Brand Vertaux 5.5 mm Pedicle Screw System?

Auxein Brand Vertaux 5.5 mm Pedicle Screw System is manufactured by Auxein Medical Private Limited/71164.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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