510(k) Report

Devices descending from K171538

19 later devices reach Cure™ Lumbar Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+1K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+1K200885Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation202012—
+1K201136Cure™ Lumbar Plate SystemMeditech Spine, LLC20200—
+1K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+1K180090Cure™ Lumbar Plate SystemMeditech Spine, LLC20181—
+2K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+2K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+2K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+2K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—