510(k) Report

Devices descending from K211710

2 later devices reach Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+2K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—