510(k) Report

Devices descending from K031989

5 later devices reach Ortrautek Orthognathic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+2K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+3K170697GBR systemSurgident20182—
+4K222367Save GBRDentis Co., Ltd.20230—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—