510(k) Report

Devices descending from K082108

19 later devices reach Obc Bone Anchored Hearing Aid System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103594Ponto Pro PowerOticon Medical AB201111—
+1K090996Ponto ProOticon Medical AB200918—
+2K132775Ponto Plus and Ponto Plus PowerOticon Medical AB201310—
+2K100193Otomag Bone Conduction Hearing SystemSophono, Inc.20105—
+3K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB20165—
+3K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System /…Oticon Medical AB20153—
+3K102199Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M)Sophono, Inc.20114—
+4K213733Ponto 5 SuperPowerOticon Medical AB20211—
+4K190540Ponto 4Oticon Medical AB20193—
+4K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas20180—
+4K152820Ponto Bone Anchored Hearing SystemOticon Medical AB20160—
+4K152067Ponto bone anchored hearing systemOticon Medical AB20151—
+4K132189Otomag Bone Conducation Hearing SystemSophono, Inc.20132—
+4K123962Otomag Bone Conduction Hearing SystemSophono, Inc.20130—
+5K261142Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical AB20260—
+5K211640Ponto 5 MiniOticon Medical AB20212—
+5K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB20210—
+5K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc.20161—
+6K243041contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh20250—