510(k) Report

Devices descending from K171327

5 later devices reach Tyber Medical Wedge System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+3K252254Osteotomy Wedge SystemSinaptic Surgical20250—