510(k) Report

Devices descending from K080250

5 later devices reach Leksell Surgiplan, Model 1006947 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092192Waypoint Stereotactic SystemFHC, Inc.20104—
+2K231141STarFix Designer Software C0265FHC, Inc.20230—
+2K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230—
+2K132611Microtable SystemFred Haer Company, Inc.20141—
+3K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc.20240—