510(k) Report

Devices descending from K150394

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171327Tyber Medical Wedge SystemTyber Medical, LLC20175—
+2K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+3K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+3K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+3K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+4K252254Osteotomy Wedge SystemSinaptic Surgical20250—