510(k) Report

Devices descending from K171421

6 later devices reach VERTICALE® Posterior Spinal Fixation System/VERTICALE® System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+1K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+1K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+1K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+2K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—