Humerus & Ulna System
K-Number: K213108 · 2022-11-04
ApplicantAuxein Medical Private Limited
Decision Date2022-11-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Humerus & Ulna System is a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-11-04 under approval number K213108. 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 Humerus & Ulna System?
Humerus & Ulna System is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K213108.
When was Humerus & Ulna System approved by the FDA?
Humerus & Ulna System received FDA 510(k) clearance on 2022-11-04, under approval number K213108.
What company makes Humerus & Ulna System?
Humerus & Ulna System is manufactured by Auxein Medical Private Limited.
What is the FDA product code for Humerus & Ulna System?
The FDA product code for Humerus & Ulna System is HRS.
Related Clinical Trials
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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.