510(k) Report

Devices descending from K132991

9 later devices reach C-Box Peek Cervical Ibf through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+2K242303MOD-COrthomod, LLC20260—
+2K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+2K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+2K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+2K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+3K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+3K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+4K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—