510(k) Report

Devices descending from K130913

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+1K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+1K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—