510(k) Report

Devices descending from K050642

8 later devices reach Orthoblast II Putty and Paste through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103036Allofuse PlusAllosource, Inc.20110—
+1K091193Accell EVO3CIsotis Orthobiologics, Inc.200921
+1K070751Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc.20071—
+1K061668Optecure +CCCExactech, Inc.20062—
+2K212135Dry DBM- A PuttySeaspine Corporation20211—
+2K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+3K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+3K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—