510(k) Report

Devices descending from K191457

1 later device reach BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)Med-El Elektromedizinische Geraete GmbH20200—