510(k) Report

Devices descending from K080355

5 later devices reach Leksell Stereotactic System with Reusable Fixation Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190887Leksell Vantage Stereotactic SystemElekta Instrument AB201933
+1K171123Leksell Vantage Stereotactic SystemElekta Instrument AB201742
+2K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB20260—
+2K210700NaviNetics D1 Stereotactic SystemNavinetics, Inc.20211—
+3K231392NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc.202301