510(k) Report

Devices descending from K182477

15 later devices reach Cervical Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+2K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+2K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+2K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+4K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—