Cleared Traditional

VERITAS COLLAGEN MATRIX

K030879 · Synovis Surgical Innovations · General & Plastic Surgery
Apr 2003
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K030879 is an FDA 510(k) clearance for the VERITAS COLLAGEN MATRIX, a Mesh, Surgical, Collagen, Staple Line Reinforcement (Class II — Special Controls, product code OXE), submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on April 24, 2003, 35 days after receiving the submission on March 20, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K030879 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2003
Decision Date April 24, 2003
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OXE — Mesh, Surgical, Collagen, Staple Line Reinforcement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.