510(k) Report

Devices descending from K041118

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+8K162575Z-LINKPC SystemZavation, LLC20173—
+8K151977icotec Pedicle SystemIcotec AG201630—
+8K150918PASS OCT Spinal SystemMedicrea International SA201513—
+8K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+8K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+8K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+8K141284Caspian Spinal SystemK2m, Inc.20140—
+8K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+8K131833Centurion Poct SystemOrthofix, Inc.20142—
+8K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+8K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+8K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+8K120998Solstice Cross ConnectorLife Spine20121—
+9K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+9K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+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—
+9K203023Pisces Spinal SystemOrtho Development Corporation20210—
+9K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+9K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+9K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+9K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+9K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+9K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+9K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+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—
+10K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+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—
+10K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+10K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+10K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+10K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+10K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+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
+11K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+12K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+12K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—