Cleared Traditional

K090954 - ATLAS WOUND MATRIX (FDA 510(k) Clearance)

K090954 · Wrightmedicaltechnologyinc · General & Plastic Surgery device

Jul 2009

Decision

115d

Days

—

Risk

K090954 is an FDA 510(k) clearance for the ATLAS WOUND MATRIX. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 30, 2009, 115 days after receiving the submission on April 6, 2009.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K090954 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 06, 2009
Decision Date	July 30, 2009
Days to Decision	115 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF