510(k) Report

Devices descending from K940631

559 later devices reach Cross Medical - Synergy (TM) Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+6K130176Firebird Spinal Fixation SystemOrthofix20135—
+6K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240963Spinal SystemTeslake, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+7K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+8K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—