510(k) Report

Devices descending from K052170

13 later devices reach Seaspine VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071726ZUMASeaspine, Inc.200712—
+2K124034Mectalif AnteriorMedacta International201311—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—