510(k) Report

Devices descending from K060615

822 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K240699SCARLET® AC-TiSpineart SA20240—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+10K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K223326Axiom PSR SystemRestor3D202301
+10K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+10K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+10K190751Connector SystemOrthofix, Inc.20193—
+10K182182YUKON OCT Spinal SystemK2m20185—
+10K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+11K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+11K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+11K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+11K193129Yukon OCT Spinal SystemK2m, Inc.202001