510(k) Report

Devices descending from K181115

8 later devices reach CxHA PEEK Cervical IBF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242303MOD-COrthomod, LLC20260—
+1K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+1K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+1K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+1K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+2K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+2K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+3K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—