510(k) Report

Devices descending from K100360

4 later devices reach BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas20180—
+1K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc.20161—
+1K121317Cochlear Baha Implant SystemCochlear Americas20121—
+2K243041contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh20250—