510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K130176Firebird Spinal Fixation SystemOrthofix20135—
+6K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+6K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+7K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240963Spinal SystemTeslake, Inc.20240—
+7K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+7K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K182182YUKON OCT Spinal SystemK2m20185—