510(k) Report

Devices descending from K032476

753 later devices reach Nuvasive Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203444BEE HA CageNGMedical GmbH20211—
+8K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+8K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K182608Oyster ACIF CageSilony Medical GmbH20190—
+8K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+8K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261408SABER-XA SystemElevation Spine20260—
+9K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K250560BEE HANGMedical GmbH20250—
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—