510(k) Report

Devices descending from K022793

1,705 later devices reach Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+8K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+8K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+8K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+8K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+8K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+8K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+8K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+8K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+8K120869Anchor-L Lumbar CageStryker Spine2012638—
+8K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+8K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+8K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+8K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+8K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+8K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+8K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+8K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+8K121116Plateau Spacer SystemLife Spine201213—
+8K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+8K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+8K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+8K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+8K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+8K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+8K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+8K103369Vault Alif SystemSpinal USA201110—
+8K093093Small Plateau Spacer SystemLife Spine2010393—
+8K101301Stalif MidlineCentinel Spine2010474—
+8K083475Lucent MagnumSpinal Elements, Inc.2009834—
+8K081711Lucent Magnum+Spinal Elements, Inc.20080—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+9K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+9K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—