510(k) Report

Devices descending from K094025

838 later devices reach Crescent Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+1K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+1K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+1K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+1K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+1K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+1K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+1K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+1K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+1K150847Foundation Interbody DevicesCorelink, LLC201529—
+1K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+1K133893Sterispine LC CageSafe Orthopaedics20141—
+1K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+1K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+1K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+1K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+1K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+1K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+2K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K260810Anteralign LS coverplateTyber Medical, LLC20260—
+2K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+2K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+2K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+2K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+2K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+2K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K153621Juliet® TiSpineart2016751
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+2K151756Sterispine LC CageSafe Orthopaedics20150—
+2K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K142277Juliet POSpineart2014119—
+2K140474Juliet OLSpineart2014120—
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+2K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+2K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+2K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+2K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+2K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—