510(k) Report

Devices descending from K073460

114 later devices reach Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+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—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—