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FDA 510(k)

InCore Subtalar System

K-Number: K213301 · 2021-12-21

ApplicantNextremity Solutions, Inc.
Decision Date2021-12-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InCore Subtalar System is a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2021-12-21 under approval number K213301. 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 InCore Subtalar System?

InCore Subtalar System is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K213301.

When was InCore Subtalar System approved by the FDA?

InCore Subtalar System received FDA 510(k) clearance on 2021-12-21, under approval number K213301.

What company makes InCore Subtalar System?

InCore Subtalar System is manufactured by Nextremity Solutions, Inc..

What is the FDA product code for InCore Subtalar System?

The FDA product code for InCore Subtalar 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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