510(k) Report

Devices descending from K040284

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+12K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+12K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+12K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+12K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+13K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—