510(k) Report

Devices descending from K171848

55 later devices reach FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+1K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+1K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+1K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+1K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K261408SABER-XA SystemElevation Spine20260—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—