510(k) Report

Devices descending from K051093

2 later devices reach Osteopore PCL Scaffold through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.20260—
+1K123633TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc.20130—