510(k) Report

Devices descending from K161037

9 later devices reach Tarsa-Link Stand-Alone Wedge Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+1K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+1K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+1K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+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—
+2K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+3K252254Osteotomy Wedge SystemSinaptic Surgical20250—