510(k) Report

Devices descending from K162786

6 later devices reach PASS LP Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+1K182240PASS LP Spinal SystemMedicrea International SA20182—
+2K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K190376PASS LP Spinal SystemMedicrea International SA201915
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—