510(k) Report

Devices descending from K112837

5 later devices reach Vilex EZ-Staple (Memory Bone Fixation Staple) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+1K231493NITINEX Memory Compression StapleVilex, LLC20230—
+1K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC201622
+1K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+2K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—