510(k) Report

Devices descending from K220922

3 later devices reach Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231204Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette…Cochlear20232—
+2K240155Cochlear Osia SystemCochlear Americas20241—
+3K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3…Cochlear Americas20260—