510(k) Report

Devices descending from K031980

3 later devices reach Modification to Leksell Stereotactic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051746Elekta Esarte Frame SystemElekta Instrument AB20052—
+2K112210FraxionMedical Intelligence Medizintechnik GmbH20111—
+3K132908Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base…Medtec, Inc.20140—