510(k) Report

Devices descending from K191535

6 later devices reach CoLink® Mini Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+1K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+2K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+3K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+3K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+4K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—