510(k) Report

Devices descending from K143394

18 later devices reach Acumed Small Fragment Base Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+1K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+1K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+2K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+3K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—