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FDA 510(k)

Nexta PEEK Hammertoe Correction System

K-Number: K211996 · 2021-09-23

ApplicantNextremity Solutions, Inc.
Decision Date2021-09-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Nexta PEEK Hammertoe Correction 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 2021-09-23 under 510(k) number K211996. 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 Nexta PEEK Hammertoe Correction System?

Nexta PEEK Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K211996.

When did Nexta PEEK Hammertoe Correction System receive FDA 510(k) clearance?

Nexta PEEK Hammertoe Correction System received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211996.

Who is the listed applicant for Nexta PEEK Hammertoe Correction 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 Nexta PEEK Hammertoe Correction System?

The FDA product code for Nexta PEEK Hammertoe Correction System is HWC. This falls under the Cardiovascular category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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