FDA 510(k)

Vector® Hammertoe Correction System

K-Number: K213421 · 2021-11-19

ApplicantNvision Biomedical Technologies, Inc.

Decision Date2021-11-19

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Vector® Hammertoe Correction System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2021-11-19 under approval number K213421. 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 Vector® Hammertoe Correction System?

Vector® Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K213421.

When was Vector® Hammertoe Correction System approved by the FDA?

Vector® Hammertoe Correction System received FDA 510(k) clearance on 2021-11-19, under approval number K213421.

What company makes Vector® Hammertoe Correction System?

Vector® Hammertoe Correction System is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for Vector® Hammertoe Correction System?

The FDA product code for Vector® Hammertoe Correction System is HWC. This falls under the Cardiovascular category.

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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.