510(k) Report

Devices descending from K191130

2 later devices reach Customized Contour Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232593FITme Customized Silicone ImplantKeosan Trading Co.20230—
+1K200610Customized Contour ImplantImplantech Associates, Inc.20200—