510(k) Report

Devices descending from K181295

17 later devices reach Genesys Spine AIS-C Cervical Stand-Alone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+1K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+1K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+1K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+1K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+2K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+2K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+2K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K261279DeltaNEC Interbody SystemNexus Spine20260—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—