510(k) Report

Devices descending from K100805

3 later devices reach Gallery Laminoplasty Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20231—
+1K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+2K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20240—