510(k) Report

Devices descending from K082926

171 later devices reach Zuma, Model 55-XXXX/56-XXXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+1K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+1K092521ZUMA-CSeaspine, Inc.2010168—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K111272Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc.20117—
+2K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K173128Alamo® CAlliance Partners, LLC20182—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+3K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+3K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+3K150455RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc.20150—
+3K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K263049SABER-C SystemElevation Spine20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—