510(k) Report

Devices descending from K180025

6 later devices reach Centurion POCT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+1K201481Centurion POCT SystemOrthofix, Inc.20203—
+1K200896Solstice CCILife Spine, Inc.20200—
+2K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—