510(k) Report

Devices descending from K091988

101 later devices reach Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+1K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+1K110045Interfuse DA Invertebral Body Fusion DeviceVertebral Technologies, Inc.20110—
+1K102277Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201098—
+2K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+2K110226Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201190—
+3K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+3K142392Zavation Posterior LEIFZavation, LLC20150—
+3K123913Latis SpacerGlobus Medical, Inc.201388—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K133717Longbow Spacer SystemLife Spine20149—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+5K190721LongBow TiLife Spine, Inc.20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K201585Monterey AL Interbody SystemStryker Corporation202044
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—