510(k) Report

Devices descending from K013962

900 later devices reach Equation Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+10K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+10K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+10K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+10K223294SpineJack® Expansion KitStryker Instruments20221—
+10K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+10K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+10K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+10K222698CUVIS-spineCurexo, Inc.20220—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+10K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+10K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+10K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+10K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+10K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+10K201585Monterey AL Interbody SystemStryker Corporation202044
+10K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+10K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+10K193129Yukon OCT Spinal SystemK2m, Inc.202001
+10K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+10K182470Plateau Spacer SystemLife Spine20180—
+10K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+10K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+10K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+10K161149PASS OCT Spinal SystemMedicrea International SA20160—
+10K160756PASS OCT Spinal SystemMedicrea International SA20160—
+10K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+10K153169PASS OCT Patient Specific RodsMedicrea International20164—
+10K152211PCT SystemCentinel Spine, Inc.20150—
+10K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+10K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+11K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+11K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+11K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+11K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K250637VCFix Spinal SystemAmber Implants20250—
+11K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+11K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+11K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+11K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+11K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+11K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+11K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+11K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+11K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+11K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+11K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+11K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+11K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+11K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+11K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+11K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+11K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+11K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+11K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+11K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+11K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+11K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+11K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+12K261279DeltaNEC Interbody SystemNexus Spine20260—
+12K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+12K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+12K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+12K240699SCARLET® AC-TiSpineart SA20240—
+12K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+12K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+12K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+12K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+12K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+12K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+12K223326Axiom PSR SystemRestor3D202301
+12K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+13K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+13K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402