510(k) Report

Devices descending from K082615

7 later devices reach Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172130Resorbable Mesh DeviceSeaSpine Orthopedics Corporation201721
+1K122513Cleared Under Grafton II EdbmMedtronic Sofamor Danek, Inc.20134—
+1K123691Magnifuse Bone Graft (Cleared as Grafton II Edbm)Medtronic Sofamor Danek, Inc.20135—
+2K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+2K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation20200—
+2K193040Resorbable Mesh DeviceSeaSpine Orthopedics Corporation20190—
+2K131673Magnifuse Bone Graft, Magifuse II Bone GraftMedtronic Sofamor Danek USA, Inc.20130—