510(k) Report

Devices descending from K090607

2 later devices reach Blue Sky Bio Plan, Version .38 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190096R2GATEMegagen Implant Co., Ltd.20191—
+2K223909R2GATE Lite TMMegagen Implant Co., Ltd.20230—