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FDA 510(k)

DuoHex CH Cannulated Hammertoe System

K-Number: K200840 · 2020-06-26

ApplicantNextremity Solutions, Inc.
Decision Date2020-06-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DuoHex CH Cannulated Hammertoe System is the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200840. 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 DuoHex CH Cannulated Hammertoe System?

DuoHex CH Cannulated Hammertoe System is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K200840.

When did DuoHex CH Cannulated Hammertoe System receive FDA 510(k) clearance?

DuoHex CH Cannulated Hammertoe System received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200840.

Who is the listed applicant for DuoHex CH Cannulated Hammertoe System?

The FDA 510(k) record lists Nextremity Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for DuoHex 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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