ToeTac Hammertoe Fixation System

FDA 510(k) K150443 · Restore Surgical, LLC Dba Instratek

Substantially Equivalent

510(k) numberK150443

Submission

Device name
ToeTac Hammertoe Fixation System
Applicant
Restore Surgical, LLC Dba Instratek
Houston, TX, US
Received
February 20, 2015
Decision date
June 4, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HWC – Screw, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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More from Arthrex, Inc.

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K162321EasyClip XpressJDR · Traditional 02/10/2017SE
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Questions and answers

When was ToeTac Hammertoe Fixation System cleared by the FDA?

ToeTac Hammertoe Fixation System (K150443) received a 510(k) decision of Substantially Equivalent on June 4, 2015, 104 days after the submission was received.

What is the product code of K150443?

The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.