510(k) Report

Devices descending from K131449

235 later devices reach Coalition Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+4K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230583Tryptik TiSpineart SA20231—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K192897icotec Cervical CageIcotec AG20201—
+5K263049SABER-C SystemElevation Spine20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+5K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—