FDA 510(k)

ToeTac 10° Hammertoe Fixation System

K-Number: K161778 · 2016-11-22

ApplicantRestore Surgical, LLC Dba Instratek

Decision Date2016-11-22

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ToeTac 10° Hammertoe Fixation System is a medical device manufactured by Restore Surgical, LLC Dba Instratek. It received FDA 510(k) clearance on 2016-11-22 under approval number K161778. 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 ToeTac 10° Hammertoe Fixation System?

ToeTac 10° Hammertoe Fixation System is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Restore Surgical, LLC Dba Instratek. The 510(k) number is K161778.

When was ToeTac 10° Hammertoe Fixation System approved by the FDA?

ToeTac 10° Hammertoe Fixation System received FDA 510(k) clearance on 2016-11-22, under approval number K161778.

What company makes ToeTac 10° Hammertoe Fixation System?

ToeTac 10° Hammertoe Fixation System is manufactured by Restore Surgical, LLC Dba Instratek.

What is the FDA product code for ToeTac 10° Hammertoe Fixation System?

The FDA product code for ToeTac 10° Hammertoe Fixation 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.