510(k) Report

Devices descending from K031302

911 later devices reach Sustain Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K182349Concorde LiftMedos International SARL20190—
+12K173537Concorde Lift™Medos International SARL20181—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+13K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+13K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+13K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+13K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+13K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+13K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+13K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+14K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—