Axis Charcot Fixation System
K-Number: K211261 · 2021-05-28
ApplicantExtremity Medical, LLC
Decision Date2021-05-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Axis Charcot Fixation System is a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2021-05-28 under approval number K211261. 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 Axis Charcot Fixation System?
Axis Charcot Fixation System is a medical device that received FDA 510(k) clearance on 2021-05-28. It is manufactured by Extremity Medical, LLC. The 510(k) number is K211261.
When was Axis Charcot Fixation System approved by the FDA?
Axis Charcot Fixation System received FDA 510(k) clearance on 2021-05-28, under approval number K211261.
What company makes Axis Charcot Fixation System?
Axis Charcot Fixation System is manufactured by Extremity Medical, LLC.
What is the FDA product code for Axis Charcot Fixation System?
The FDA product code for Axis Charcot Fixation 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.