510(k) Report

Devices descending from K980199

10 later devices reach Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K102656Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa)20101—
+1K021618Osa Rigid Internal Fixation SystemOsteomed Corp.20026—
+2K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+2K031989Ortrautek Orthognathic SystemTekka20035—
+3K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+4K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+5K170697GBR systemSurgident20182—
+6K222367Save GBRDentis Co., Ltd.20230—
+6K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—