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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 the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2023-11-30 under 510(k) 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. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K221787.

When did Auxein's DHS/DCS Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for Auxein's DHS/DCS Plate System?

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

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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Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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