510(k) Report

Devices descending from K051408

6 later devices reach Intelifuse, Inc. Warm System with Stimulinks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc.20143—
+1K071477Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC20071—
+2K162321EasyClip XpressRestore Surgical, LLC Dba Instratek20172—
+2K141550Instafix Shape Memory Fixation SystemOt Medical20140—
+3K210582EasyClip® and EasyClip® XpressStryker GmbH20221—
+4K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—