510(k) Report

Devices descending from K080822

708 later devices reach VU Apod Intervertabral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+10K221578Hexanium ACIFSpinevision, S.A.S.20224—
+10K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—