510(k) Report

Devices descending from K181113

14 later devices reach CoLink™ Afx Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+1K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+1K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+1K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+1K201149CoLink Plating SystemIn2bones USA, LLC20200—
+1K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+1K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+1K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+1K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+2K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+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—