510(k) Report

Devices descending from K113348

591 later devices reach Cougar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+5K191134IB3D AlifMedicrea International SA20191—
+5K1803473d CageFims Co., Ltd.20190—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243188Cylox® STSignus Medizintechnik GmbH20250—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+6K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+6K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+6K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K230583Tryptik TiSpineart SA20231—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K221578Hexanium ACIFSpinevision, S.A.S.20224—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—