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FDA 510(k)

FLEXFUSION (TM) FIXATION IMPLANT

K-Number: K110445 · 2011-03-17

ApplicantNextremity Solutions, LLC
Decision Date2011-03-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FLEXFUSION (TM) FIXATION IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions, LLC. It received FDA 510(k) clearance on 2011-03-17 under 510(k) number K110445. 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 FLEXFUSION (TM) FIXATION IMPLANT?

FLEXFUSION (TM) FIXATION IMPLANT is a medical device that received FDA 510(k) clearance on 2011-03-17. The listed applicant is Nextremity Solutions, LLC. The 510(k) number is K110445.

When did FLEXFUSION (TM) FIXATION IMPLANT receive FDA 510(k) clearance?

FLEXFUSION (TM) FIXATION IMPLANT received FDA 510(k) clearance on 2011-03-17, under 510(k) number K110445.

Who is the listed applicant for FLEXFUSION (TM) FIXATION IMPLANT?

The FDA 510(k) record lists Nextremity Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXFUSION (TM) FIXATION IMPLANT?

The FDA product code for FLEXFUSION (TM) FIXATION IMPLANT is HWC. This falls under the Cardiovascular category.

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Other records listing Nextremity Solutions, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122031NEXTRA TI HAMMERTOE CORRECTION SYSTEM

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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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