510(k) Report

Devices descending from K220875

4 later devices reach HAcancellous PEEK-C Porous HA PEEK Cervical IBF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+1K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+1K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+2K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—