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 a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2021-09-23 under approval 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. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K211996.
When was Nexta PEEK Hammertoe Correction System approved by the FDA?
Nexta PEEK Hammertoe Correction System received FDA 510(k) clearance on 2021-09-23, under approval number K211996.
What company makes Nexta PEEK Hammertoe Correction System?
Nexta PEEK Hammertoe Correction System is manufactured by Nextremity Solutions, Inc..
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.