510(k) Report

Devices descending from K172484

7 later devices reach A-CIFT SoloFuse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+2K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+2K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—