510(k) Report

Devices descending from K230639

2 later devices reach Align Cervical Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+2K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—