510(k) Report

Devices descending from K061397

6 later devices reach Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc.20085—
+2K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+2K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+2K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+3K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+3K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—