510(k) Report

Devices descending from K170399

105 later devices reach Endoskeleton TO Interbody Fusion Device (IBD) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—