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 a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-03-14 under approval 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. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K211324.
When was 2.4mm Distal Radius System approved by the FDA?
2.4mm Distal Radius System received FDA 510(k) clearance on 2022-03-14, under approval number K211324.
What company makes 2.4mm Distal Radius System?
2.4mm Distal Radius System is manufactured by Auxein Medical Private Limited.
What is the FDA product code for 2.4mm Distal Radius System?
The FDA product code for 2.4mm Distal Radius System is HRS.
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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.