510(k) Report

Devices descending from K072597

10 later devices reach Pro-Dense Core Decompression Procedure Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+1K132656Prodense Bone Graft SubstituteWrightmedicaltechnologyinc20141—
+2K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+2K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+2K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+2K141746AS20 Composite GraftWrightmedicaltechnologyinc20140—
+3K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+3K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K223915TactosetAnika Therapeutics, Inc.20231—