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FDA 510(k)

Clavicle and Scapula System

K-Number: K240181 · 2024-10-09

ApplicantAuxein Medical Pvt., Ltd.
Decision Date2024-10-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Clavicle and Scapula System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Pvt., Ltd.. It received FDA 510(k) clearance on 2024-10-09 under 510(k) number K240181. 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 Clavicle and Scapula System?

Clavicle and Scapula System is a medical device that received FDA 510(k) clearance on 2024-10-09. The listed applicant is Auxein Medical Pvt., Ltd.. The 510(k) number is K240181.

When did Clavicle and Scapula System receive FDA 510(k) clearance?

Clavicle and Scapula System received FDA 510(k) clearance on 2024-10-09, under 510(k) number K240181.

Who is the listed applicant for Clavicle and Scapula System?

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

What is the FDA product code for Clavicle and Scapula System?

The FDA product code for Clavicle and Scapula System is HRS.

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

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

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