510(k) Report

Devices descending from K780132

6 later devices reach Implant, Hinge Toe, Flex. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981194Futura Biomedical Flexible Great Toe ImplantNexa Orthopedics, Inc.19985—
+2K153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC20162—
+2K023086Classic Great Toe ImplantNexa Orthopedics, Inc.20021—
+3K191966NewPrim SystemBrm Extremities20200—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K023562Modification to Classic Great Toe ImplantNexa Orthopedics, Inc.20020—