510(k) Report

Devices descending from K133082

5 later devices reach Osteosymbionics Patient-Specific Cranial Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC20184—
+2K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC20203—
+3K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC20202—
+4K231920Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC20231—
+5K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…Longeviti Neuro Solutions20260—