510(k) Report

Devices descending from K183557

104 later devices reach Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K223326Axiom PSR SystemRestor3D202301
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—