510(k) Report

Devices descending from K153609

2 later devices reach RTS Flexible 1 MPJ Implant w/Grommets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191966NewPrim SystemBrm Extremities20200—
+1K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—