510(k) Report

Devices descending from K080568

615 later devices reach X-Mesh Expandable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+9K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+9K192897icotec Cervical CageIcotec AG20201—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—