510(k) Report

Devices descending from K081917

1,008 later devices reach Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K182608Oyster ACIF CageSilony Medical GmbH20190—
+6K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+6K171425Concorde LiftMedos International SARL201782
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K182349Concorde LiftMedos International SARL20190—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K173537Concorde Lift™Medos International SARL20181—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+8K183243Velofix TLIF CageU&I Corporation20190—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—