510(k) Report

Devices descending from K140037

2 later devices reach Optimus CMF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+1K160363Optimus CMF SystemOsteonic Co., Ltd.20160—