FDA 510(k)

ToeTac™ 10° 毒指固定システム

K番号: K161778 · 2016-11-22

決定日2016-11-22

製品コードHWC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてRestore Surgical, LLC Dba Instratekを記載するその他の記録

K162321EasyClip Xpress

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