Cleared Traditional

K062915 - VERITAS COLLAGEN MATRIX
(FDA 510(k) Clearance)

K062915 · Synovis Surgical Innovations · General & Plastic Surgery device

Dec 2006

Decision

70d

Days

Class 2

Risk

K062915 is an FDA 510(k) clearance for the VERITAS COLLAGEN MATRIX. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).

Submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on December 6, 2006, 70 days after receiving the submission on September 27, 2006.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K062915 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 27, 2006
Decision Date	December 06, 2006
Days to Decision	70 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF