510(k) Report

Devices descending from K122513

4 later devices reach Cleared Under Grafton II Edbm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172130Resorbable Mesh DeviceSeaSpine Orthopedics Corporation201721
+1K131673Magnifuse Bone Graft, Magifuse II Bone GraftMedtronic Sofamor Danek USA, Inc.20130—
+2K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation20200—
+2K193040Resorbable Mesh DeviceSeaSpine Orthopedics Corporation20190—