510(k) Report

Devices descending from K921106

4 later devices reach Sterile/Single Use Eye Sphere Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972661Eye Sphere, ConformersGulden Ophthalmics1997313
+2K082850Eye SpheresProduct and Educational Services, LLC20090—
+2K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc.20071—
+3K083342Orbital Reconstructive Implant IIEvera Medical, Inc.20090—