510(k) Report

Devices descending from K070021

1 later device reach Italite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163037Intra medullary endo-transilluminating device (iMET device)WeMED Bio-Tech, Inc.20170—