510(k) Report

Devices descending from K121589

5 later devices reach Biomet Microfixation Facial Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+1K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+1K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+2K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+2K160363Optimus CMF SystemOsteonic Co., Ltd.20160—