510(k) Report

Devices descending from K161485

5 later devices reach Nanovis Intervertebral Body Fusion System and Forticore (R) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+1K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+1K171312FortiCore®Nanovis, LLC20183—
+2K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—