510(k) Report

Devices descending from K111940

19 later devices reach S 100 Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+1K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+1K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+1K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+1K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+1K162764Jazz Frame SystemImplanet, S.A.20176—
+1K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+2K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+2K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+2K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+2K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+2K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+2K171881JAZZ Passer BandImplanet, S.A.20170—
+2K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+3K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+3K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—