510(k) Report

Devices descending from K150380

4 later devices reach ProMIS Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+1K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+1K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+2K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—