510(k) Report

Devices descending from K161627

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+2K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—