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FDA 510(k)

Auxein's DHS/DCS Plate System

K-Number: K221787 · 2023-11-30

ApplicantAuxein Medical Private Limited
Decision Date2023-11-30
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Auxein's DHS/DCS Plate System is a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2023-11-30 under approval number K221787. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Auxein's DHS/DCS Plate System?

Auxein's DHS/DCS Plate System is a medical device that received FDA 510(k) clearance on 2023-11-30. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K221787.

When was Auxein's DHS/DCS Plate System approved by the FDA?

Auxein's DHS/DCS Plate System received FDA 510(k) clearance on 2023-11-30, under approval number K221787.

What company makes Auxein's DHS/DCS Plate System?

Auxein's DHS/DCS Plate System is manufactured by Auxein Medical Private Limited.

What is the FDA product code for Auxein's DHS/DCS Plate System?

The FDA product code for Auxein's DHS/DCS Plate System is KTT.

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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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