Cleared Traditional

K083039 - VERITAS COLLAGEN MATRIX (DRY)

K083039 is an FDA 510(k) clearance for VERITAS COLLAGEN MATRIX (DRY), manufactured by Synovis Surgical Innovations. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K083039 · Synovis Surgical Innovations · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
43d
Days
Class 2
Risk

K083039 is an FDA 510(k) clearance for the VERITAS COLLAGEN MATRIX (DRY). Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on November 26, 2008 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K083039

510(k) Number K083039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date November 26, 2008
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTM Mesh, Surgical

All 156
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K083039.
SECURIAN TISSUE REINFORCEMENT MATRIX
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SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
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SURGIMEND
K083898 · Tei Biosciences, Inc. · Feb 2009
LTM-BPS SURGICAL MESH
K082176 · Lifecell Corp. · Nov 2008
COLLAMEND FM IMPLANT
K082687 · C.R. Bard, Inc. · Oct 2008
PORCINE SURGICAL MESH
K081272 · Brennen Medical, LLC · Jul 2008
K083039 · VERITAS COLLAGEN MATRIX (DRY)
Download PDF FDA Summary Synovis Surgical Inno…