510(k) Report

Devices descending from K162300

2 later devices reach Reform® POCT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+2K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—