510(k) Report

Devices descending from P970015

1,426 later devices reach Inter Fix Threaded Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K182608Oyster ACIF CageSilony Medical GmbH20190—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K173508Everest Spinal SystemK2m20189—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171519FLXfit™Expanding Orthopedics, Inc.2017711
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+6K160715AccuLIF TL and PL CageStryker Corporation20160—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K133717Longbow Spacer SystemLife Spine20149—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K141217Acculif TL and PL CageStryker Corporation20146423
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K141147Range Spinal SystemK2m, Inc.20141—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K250540SABER-C SystemElevation Spine20252—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+7K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+7K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—