510(k) Report

Devices descending from K222270

23 later devices reach HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+1K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+1K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+1K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+1K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+1K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+1K241846E3D™-C Interbody SystemEvolution Spine20246—
+1K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+1K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+1K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+2K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+2K262094E3D™-C Interbody SystemEvolution Spine20260—
+2K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+2K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+2K260038E3D™-C Interbody SystemEvolution Spine20261—
+2K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+2K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+2K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—