510(k) Report

Devices descending from K081196

13 later devices reach Spinal Usa VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+1K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K221172FOCUS Interbody SystemOc Medical Devices20220—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K140280ForticoreNanovis, LLC20149—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K171312FortiCore®Nanovis, LLC20183—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601