510(k) Report

Devices descending from K043488

1,128 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+8K161149PASS OCT Spinal SystemMedicrea International SA20160—
+8K160756PASS OCT Spinal SystemMedicrea International SA20160—
+8K153169PASS OCT Patient Specific RodsMedicrea International20164—
+8K152211PCT SystemCentinel Spine, Inc.20150—
+8K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+8K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K240699SCARLET® AC-TiSpineart SA20240—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K223326Axiom PSR SystemRestor3D202301
+9K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+9K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+9K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+9K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402