510(k) Report

Devices descending from K161671

5 later devices reach Ponto 3, Ponto 3 Power and Ponto 3 SuperPower through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213733Ponto 5 SuperPowerOticon Medical AB20211—
+1K190540Ponto 4Oticon Medical AB20193—
+1K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas20180—
+2K261142Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical AB20260—
+2K211640Ponto 5 MiniOticon Medical AB20212—