Cleared Traditional

OMNIPORE CUSTOMIZED SURGICAL IMPLANTS

K133046 · Matrix Surgical Holdings, LLC/Matrix Surgical USA · General & Plastic Surgery

May 2014

Decision

229d

Days

Class 2

Risk

About This 510(k) Submission

K133046 is an FDA 510(k) clearance for the OMNIPORE CUSTOMIZED SURGICAL IMPLANTS, a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II — Special Controls, product code KKY), submitted by Matrix Surgical Holdings, LLC/Matrix Surgical USA (Alpharetta, US). The FDA issued a Cleared decision on May 14, 2014, 229 days after receiving the submission on September 27, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3500.

Submission Details

510(k) Number	K133046 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2013
Decision Date	May 14, 2014
Days to Decision	229 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3500