510(k) Report

Devices descending from K110927

30 later devices reach Mectalif through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251016MectaLIF 3D MetalMedacta International S.A.20250—
+1K212831MectaLIF ExtensionMedacta International S.A.20211—
+1K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+1K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+1K133192Mectalif TipeekMedacta International201416—
+1K131671MectalifMedacta International201322—
+1K124034Mectalif AnteriorMedacta International201311—
+1K120024Mectalif TransforaminalMedacta International S.A.201223—
+1K112862Mecta-CMedacta International201114—
+2K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+2K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+2K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+2K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+2K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+2K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K142744Mecta-C TiPEEKMedacta International201512—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+3K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—