510(k) Report

Devices descending from K193359

14 later devices reach SureMAX Family of Cervical Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+1K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+1K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+1K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+1K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+2K253260ORIO-3D Cage SystemSpineCraft20260—
+2K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+2K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+3K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—