510(k) Report

Devices descending from K153123

12 later devices reach Genesys Spine Apache Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+1K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+1K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—