510(k) Report

Devices descending from K191489

7 later devices reach Genesys Spine 3DP Cervical Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+1K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+2K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+2K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+2K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+2K230329F3D Interbody SystemCorelink, LLC20230—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—