510(k) Report

Devices descending from K103594

11 later devices reach Ponto Pro Power through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132775Ponto Plus and Ponto Plus PowerOticon Medical AB201310—
+2K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB20165—
+2K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System /…Oticon Medical AB20153—
+3K213733Ponto 5 SuperPowerOticon Medical AB20211—
+3K190540Ponto 4Oticon Medical AB20193—
+3K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas20180—
+3K152820Ponto Bone Anchored Hearing SystemOticon Medical AB20160—
+3K152067Ponto bone anchored hearing systemOticon Medical AB20151—
+4K261142Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical AB20260—
+4K211640Ponto 5 MiniOticon Medical AB20212—
+4K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB20210—