510(k) Report

Devices descending from K020709

1,146 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+9K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+9K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+9K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+9K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+9K161149PASS OCT Spinal SystemMedicrea International SA20160—
+9K160756PASS OCT Spinal SystemMedicrea International SA20160—
+9K153169PASS OCT Patient Specific RodsMedicrea International20164—
+9K152211PCT SystemCentinel Spine, Inc.20150—
+9K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+9K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+10K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K240699SCARLET® AC-TiSpineart SA20240—
+10K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+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—
+10K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+10K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+10K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+11K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+11K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402