510(k) Report

Devices descending from K053640

6 later devices reach Integra through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111947Duet MagnaDirex Systems Corp.20120—
+1K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc.20082—
+1K062147Integra SLDirex Systems Corp.20063—
+1K061873VERT-XDirex Systems Corp.20060—
+2K252913Break WaveSonomotion, Inc.20261—
+3K261086Break WaveSonomotion, Inc.20260—