510(k) Report

Devices descending from K093447

21 later devices reach Carrigen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+1K182107CarriGen PFEtex Corporation20181—
+1K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+1K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+2K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+2K130392Kinex BioactiveGlobus Medical, Inc.20138—
+2K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+3K173008SCS 17-01Anika Therapeutics, Inc.20174—
+3K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+3K151146N-Force Fixation SystemInnovision, Inc.20151—
+3K142776Flow-ScrewFlow-Fx, LLC20151—
+3K133678Confirm BioactiveGlobus Medical, Inc.20140—
+3K132244N-Force Fixation SystemInnovision, Inc.20143—
+3K130977Signify BioactiveGlobus Medical, Inc.20131—
+4K223915TactosetAnika Therapeutics, Inc.20231—
+4K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+4K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+4K190956SCS 17-01Anika Therapeutics, Inc.20203—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—