JOF — Polymer, Ent Synthetic, Porous Polyethylene Class II

FDA Device Classification

Classification Details

Product Code
JOF
Device Class
Class II
Regulation Number
874.3620
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K200532anatomics ptyStarPoreJune 2, 2020
K171037anatomics ptyPoreStar Patient Specific ImplantDecember 27, 2017
K083621porex surgicalMEDPOR CUSTOMIZED SURGICAL IMPLANTFebruary 3, 2009
K002629pillar surgicalSILMAX CONTOUR CARVING BLOCK IMPLANTNovember 20, 2000
K771726xomedBIOSPONGE STAPES PISTONSeptember 26, 1977
K771727xomedBIOSPONGE RECONSTRUCTION DISCSSeptember 26, 1977