510(k) Report

Devices descending from K201314

7 later devices reach Restor3d Utility Wedge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC20260—
+1K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+1K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+1K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+2K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+2K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+2K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—