510(k) Report

Devices descending from K192645

7 later devices reach Trigon™ Ti Stand-Alone Wedge Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+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—
+2K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+2K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+3K252254Osteotomy Wedge SystemSinaptic Surgical20250—