510(k) Report

Devices descending from K161280

14 later devices reach Cervical Stand Alone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+1K172424Velofix™ SA Cervical CageU&I Corporation201751
+1K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+2K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+2K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+2K210573Velofix SA Cervical CageU&I Corporation20211—
+2K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+3K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—