510(k) Report

Devices descending from K060151

2 later devices reach Orbital Tissue Expander (Ote) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc.20071—
+2K083342Orbital Reconstructive Implant IIEvera Medical, Inc.20090—