510(k) Report

Devices descending from K231899

2 later devices reach HAtetracell™-C Titanium Cervical IBF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+1K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—