510(k) Report

Devices descending from DEN170009

10 later devices reach Bonebridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSOticon Medical AB20240—
+1K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)Med-El Elektromedizinische Geraete GmbH20200—
+1K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test…Cochlear Americas20195—
+1K183373BonebridgeMed-El Elektromedizinische Geraete GmbH20191—
+2K200504BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 RemoteMed-El Elektromedizinische Geraete GmbH20200—
+2K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software…Cochlear Americas20194—
+3K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor…Cochlear Americas20223—
+4K231204Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette…Cochlear20232—
+5K240155Cochlear Osia SystemCochlear Americas20241—
+6K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3…Cochlear Americas20260—