510(k) Report

Devices descending from K193153

2 later devices reach SPIRA-C Integrated Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+1K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—