JOF · Class II · 21 CFR 874.3620

FDA Product Code JOF: Polymer, Ent Synthetic, Porous Polyethylene

Leading manufacturers include Anatomics Pty, Ltd., Xomed, Inc. and Porex Surgical, Inc..

6
Total
6
Cleared
88d
Avg days
1977
Since

FDA 510(k) Cleared Polymer, Ent Synthetic, Porous Polyethylene Devices (Product Code JOF)

6 devices
1–6 of 6
Cleared Jun 02, 2020
StarPore
K200532
Anatomics Pty, Ltd.
Ear, Nose, Throat · 92d
Cleared Dec 27, 2017
PoreStar Patient Specific Implant
K171037
Anatomics Pty, Ltd.
Ear, Nose, Throat · 265d
Cleared Feb 03, 2009
MEDPOR CUSTOMIZED SURGICAL IMPLANT
K083621
Porex Surgical, Inc.
Ear, Nose, Throat · 57d
Cleared Sep 26, 1977
BIOSPONGE STAPES PISTON
K771726
Xomed, Inc.
Ear, Nose, Throat · 13d
Cleared Sep 26, 1977
BIOSPONGE RECONSTRUCTION DISCS
K771727
Xomed, Inc.
Ear, Nose, Throat · 13d

About Product Code JOF - Regulatory Context