FDA 510(k)

Clavicle and Scapula System

K-Number: K240181 · 2024-10-09

Decision Date2024-10-09

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Clavicle and Scapula System is a medical device manufactured by Auxein Medical Pvt., Ltd.. It received FDA 510(k) clearance on 2024-10-09 under approval 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. It is manufactured by Auxein Medical Pvt., Ltd.. The 510(k) number is K240181.

When was Clavicle and Scapula System approved by the FDA?

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

What company makes Clavicle and Scapula System?

Clavicle and Scapula System is manufactured by Auxein Medical Pvt., Ltd..

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

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

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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.