510(k) Report

Devices descending from K002886

3 later devices reach Implantech Composite Facial Implants (Malar, Chin, and Nasal) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172389ePTFE-Coated Auricular ImplantImplantech Associates, Inc.20180—
+1K091011Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Surgical Technology Laboratories, Inc ("Stl")20091—
+2K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd.20230—