510(k) Report

Devices descending from K112583

118 later devices reach Synthes Cortical Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191009Arsenal Plating SystemTrilliant Surgical20192—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—