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FDA 510(k)

2.4mm Distal Radius System

K-Number: K211324 · 2022-03-14

ApplicantAuxein Medical Private Limited
Decision Date2022-03-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

2.4mm Distal Radius 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 2022-03-14 under 510(k) number K211324. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2.4mm Distal Radius System?

2.4mm Distal Radius System is a medical device that received FDA 510(k) clearance on 2022-03-14. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K211324.

When did 2.4mm Distal Radius System receive FDA 510(k) clearance?

2.4mm Distal Radius System received FDA 510(k) clearance on 2022-03-14, under 510(k) number K211324.

Who is the listed applicant for 2.4mm Distal Radius 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 2.4mm Distal Radius System?

The FDA product code for 2.4mm Distal Radius System is HRS.

Other records listing Auxein Medical Private Limited as applicant

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Related Devices (Code: HRS)

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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