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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 the device name listed in this FDA 510(k) record. The listed applicant is Restore Surgical, LLC Dba Instratek. It received FDA 510(k) clearance on 2016-11-22 under 510(k) 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. The listed applicant is Restore Surgical, LLC Dba Instratek. The 510(k) number is K161778.

When did ToeTac™ 10° Hammertoe Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for ToeTac™ 10° Hammertoe Fixation System?

The FDA 510(k) record lists Restore Surgical, LLC Dba Instratek as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Restore Surgical, LLC Dba Instratek 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.

K162321EasyClip Xpress

Related Devices (Code: HWC)

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.

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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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