510(k) Report

Devices descending from K232149

2 later devices reach BowTie™ SI Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+2K250894Eminent Spine Posterior SI SystemEminent Spine20250—