510(k) Report

Devices descending from K041862

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+8K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+8K172194Connector SystemOrthofix, Inc.2017162
+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—
+8K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+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—
+9K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250637VCFix Spinal SystemAmber Implants20250—
+9K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K240699SCARLET® AC-TiSpineart SA20240—
+9K232628VADER® Pedicle SystemIcotec AG20241—
+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—
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+9K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+10K240685Salvo® Spine SystemSpine Wave, Inc.20242—