FZD — Prosthesis, Ear, Internal Class II

FDA Device Classification

FDA product code FZD covers "Prosthesis, Ear, Internal", a Class II medical device regulated under 21 CFR 878.3590. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FZD
Device Class
Class II
Regulation Number
878.3590
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172389implantech associatesePTFE-Coated Auricular ImplantJuly 18, 2018
K863939porex medicalPOREX(TM) EAR PROSTHESISOctober 24, 1986
K844960richards medical coCANAL WALL PROSTHESISFebruary 26, 1985