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FDA 510(k)

InCore TMT System

K-Number: K192578 · 2019-12-31

ApplicantNextremity Solutions, Inc.
Decision Date2019-12-31
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InCore TMT 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 2019-12-31 under 510(k) number K192578. 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 TMT System?

InCore TMT System is a medical device that received FDA 510(k) clearance on 2019-12-31. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K192578.

When did InCore TMT System receive FDA 510(k) clearance?

InCore TMT System received FDA 510(k) clearance on 2019-12-31, under 510(k) number K192578.

Who is the listed applicant for InCore TMT 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 InCore TMT System?

The FDA product code for InCore TMT 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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