510(k) Report

Devices descending from K011406

2,048 later devices reach Spinal Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251016MectaLIF 3D MetalMedacta International S.A.20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+5K223043The Integrity Spine Core SystemIntegrity Spine20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212831MectaLIF ExtensionMedacta International S.A.20211—
+5K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+5K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+5K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K181899Roccia® PlifSilony Medical GmbH20180—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—