510(k) Report

Devices descending from K130548

602 later devices reach Epicage Interbody Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—