510(k) Report

Devices descending from K010852

3 later devices reach Osmed Tissue Expander through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060151Orbital Tissue Expander (Ote)Innovia, LLC20062—
+2K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc.20071—
+3K083342Orbital Reconstructive Implant IIEvera Medical, Inc.20090—