Cleared Traditional

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend

K170763 · Acell, Inc. · General & Plastic Surgery

Jun 2017

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K170763 is an FDA 510(k) clearance for the Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on June 8, 2017, 87 days after receiving the submission on March 13, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K170763 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2017
Decision Date	June 08, 2017
Days to Decision	87 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF