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FDA 510(k)

Nextra CH Cannulated Hammertoe System

K-Number: K213530 · 2021-12-09

ApplicantNextremity Solutions, Inc.
Decision Date2021-12-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Nextra CH Cannulated Hammertoe System is a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2021-12-09 under approval number K213530. 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 Nextra CH Cannulated Hammertoe System?

Nextra CH Cannulated Hammertoe System is a medical device that received FDA 510(k) clearance on 2021-12-09. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K213530.

When was Nextra CH Cannulated Hammertoe System approved by the FDA?

Nextra CH Cannulated Hammertoe System received FDA 510(k) clearance on 2021-12-09, under approval number K213530.

What company makes Nextra CH Cannulated Hammertoe System?

Nextra CH Cannulated Hammertoe System is manufactured by Nextremity Solutions, Inc..

What is the FDA product code for Nextra CH Cannulated Hammertoe System?

The FDA product code for Nextra CH Cannulated Hammertoe 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.

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