510(k) Report

Devices descending from K123128

5 later devices reach Seri Surgical Scaffold through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172545SERI ContourSofregen Medical, Inc.20170—
+1K140533Galaflex MeshTepha, Inc.20143—
+2K202425SurgiLattice scaffoldTepha, Inc.20210—
+2K162922GalaFORM 3DTepha, Inc.20170—
+2K161092GalaSHAPE 3DTepha, Inc.201611