Auxein Nailing System
K-Number: K210792 · 2021-08-25
ApplicantAuxein Medical Private Limited
Decision Date2021-08-25
Product CodeHWC
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 2021-08-25 under approval number K210792. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. 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 2021-08-25. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K210792.
When was Auxein Nailing System approved by the FDA?
Auxein Nailing System received FDA 510(k) clearance on 2021-08-25, under approval number K210792.
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 HWC. This falls under the Cardiovascular category.
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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.