510(k) Report

Devices descending from K003015

5 later devices reach Ssc's PCL Monofilament Sas, Violet, Coated, Model TBD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051093Osteopore PCL ScaffoldOsteopore, Inc.200621
+1K020882Sharpoint Ultraplug Extended Wear PlugSurgical Specialties Corp20021—
+2K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.20260—
+2K123633TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc.20130—
+2K053333Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc.20060—