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FDA 510(k)

InCore® Lapidus System

K-Number: K180257 · 2018-04-25

ApplicantNextremity Solutions, Inc.
Decision Date2018-04-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InCore® Lapidus 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 2018-04-25 under 510(k) number K180257. 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® Lapidus System?

InCore® Lapidus System is a medical device that received FDA 510(k) clearance on 2018-04-25. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K180257.

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

InCore® Lapidus System received FDA 510(k) clearance on 2018-04-25, under 510(k) number K180257.

Who is the listed applicant for InCore® Lapidus 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® Lapidus System?

The FDA product code for InCore® Lapidus 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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