510(k) Report

Devices descending from K012868

57 later devices reach Micromedics Fibrijet Aerosol Applicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191659Instylla Delivery KitInstylla, Inc.20193—
+1K122122Regen Spray Applicator,Regen Lab SA20120—
+1K050998Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063Confluent Surgical,Inc20051—
+1K021071PCCS Graft Delivery SystemBiomet, Inc.2002491
+2K213632Instylla Delivery KitInstylla, Inc.20221—
+2K202544Instylla Delivery KitInstylla, Inc.20212—
+2K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC)20141—
+2K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.200747—
+2K070814Modification to Confluent Surgical Micromyst Applicator and Air PumpConfluent Surgical,Inc20070—
+2K030555GPS Platelet Separation Kit with Anticoagulant Acd-aBiomet, Inc.20030—
+3K253769Instylla Delivery KitInstylla, Inc.20250—
+3K160978LITe BIO Delivery SystemStryker Corporation20160—
+3K151543Graft Delivery Device with Integrated StyletMicromedics, Inc. (D/B/A Nordson Medical)20150—
+3K141762Perfuse Percutaneous Decompression SystemBiomet, Inc.201401
+3K100754Graft Delivery System Model SA-6115Micromedics, Inc.201045—
+4K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC201141—
+4K110787Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15)Orthogem Limited20111—
+5K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)Orthogem, Ltd.20150—
+5K133021Mixing Syringe SystemZimmer Knee Creations, Inc.201432—
+5K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC201240—
+6K143488InFill Graft Delivery SystemPinnacle Spine Group, LLC20140—
+6K142661Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC201415—
+6K141245Etex Mixing and Delivery SystemEtex Corporation201431—
+7K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC20240—
+7K231456Avitus® DragonWing Large Volume Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+7K230492Avitus® Precision Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+7K190996Bonus Therapeutics Mixing and Delivery SystemBonus Therapeutics, Ltd.20190—
+7K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+7K161447HydroSet XTOrthovita, Inc.2016102
+7K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.201621—
+8K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+8K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+8K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+8K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+8K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+8K210997PreferX Delivery SystemMd3, LLC20210—
+8K2004313D GraftRasp SystemSurgentec20201—
+8K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+8K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+8K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+8K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+8K173008SCS 17-01Anika Therapeutics, Inc.20174—
+9K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+9K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+9K223915TactosetAnika Therapeutics, Inc.20231—
+9K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+9K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+9K2019003D GraftRasp SystemSurgentec20200—
+9K201338Allograft MIS Delivery SystemLifenet Health20202—
+9K190956SCS 17-01Anika Therapeutics, Inc.20203—
+9K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+9K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+10K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+10K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+10K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+10K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+11K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—