510(k) Report

Devices descending from K030208

121 later devices reach Imbibe II Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210997PreferX Delivery SystemMd3, LLC20210—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+6K2004313D GraftRasp SystemSurgentec20201—
+6K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+6K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+6K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+6K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+6K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+6K151146N-Force Fixation SystemInnovision, Inc.20151—
+6K142776Flow-ScrewFlow-Fx, LLC20151—
+6K132244N-Force Fixation SystemInnovision, Inc.20143—
+7K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+7K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+7K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+7K2019003D GraftRasp SystemSurgentec20200—
+7K201338Allograft MIS Delivery SystemLifenet Health20202—
+7K173556Injection ScrewBiedermann Medtech, Inc.20180—
+8K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+9K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—