Cleared Traditional

MEDPOR CUSTOMIZED SURGICAL IMPLANT

K083621 · Porex Surgical, Inc. · Ear, Nose, Throat

Feb 2009

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K083621 is an FDA 510(k) clearance for the MEDPOR CUSTOMIZED SURGICAL IMPLANT, a Polymer, Ent Synthetic, Porous Polyethylene (Class II — Special Controls, product code JOF), submitted by Porex Surgical, Inc. (Newnan, US). The FDA issued a Cleared decision on February 3, 2009, 57 days after receiving the submission on December 8, 2008. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K083621 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2008
Decision Date	February 03, 2009
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF