Auxein Nailing System
K-Number: K192003 · 2020-06-10
ApplicantAuxein Medical Private Limited
Decision Date2020-06-10
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Auxein Nailing System is a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2020-06-10 under approval number K192003. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Auxein Nailing System?
Auxein Nailing System is a medical device that received FDA 510(k) clearance on 2020-06-10. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K192003.
When was Auxein Nailing System approved by the FDA?
Auxein Nailing System received FDA 510(k) clearance on 2020-06-10, under approval number K192003.
What company makes Auxein Nailing System?
Auxein Nailing System is manufactured by Auxein Medical Private Limited.
What is the FDA product code for Auxein Nailing System?
The FDA product code for Auxein Nailing System is JDS.
Related Clinical Trials
Other Devices by Auxein Medical Private Limited
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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.