510(k) Report

Devices descending from K040419

28 later devices reach Dynagraft II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113728Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp.20124—
+1K091193Accell EVO3CIsotis Orthobiologics, Inc.200921
+1K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+1K071849Allofuse Gel and PuttyAllosource, Inc.200811
+1K070751Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc.20071—
+1K061880Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV20075—
+1K050642Orthoblast II Putty and PasteIsotis Orthobiologics, Inc.20058—
+1K050690ConnexusIsotis Orthobiologics, Inc.20056—
+2K212135Dry DBM- A PuttySeaspine Corporation20211—
+2K171568SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse PuttyHans Biomed Corporation20180—
+2K152077MaxiGenHans Biomed Corp.20160—
+2K151271BellaFuseHans Biomed Corp.20160—
+2K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp.20140—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K103742Accell EVO3 (Formerly Accell A2I)Integra Life Sciences20110—
+2K103036Allofuse PlusAllosource, Inc.20110—
+2K081817Accell TBM-RIsotis Orthobiologics, Inc.20080—
+2K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+2K061668Optecure +CCCExactech, Inc.20062—
+2K052098Connexus, .5CC, Model 023000-005Isotis Orthobiologics, Inc.20050—
+3K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+3K213260CMFlexTMDimension Inx Corp.20220—
+3K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+3K082002Progenix PlusMedtronic Sofamor Danek20080—
+3K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+4K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+4K082463ProgenixMedtronic Sofamor Danek20080—
+4K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—