510(k) Report

Devices descending from K221535

3 later devices reach Align Lumbar Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+1K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+2K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—