Atlas Wound Matrix

FDA 510(k) K090954 · Wrightmedicaltechnologyinc

Substantially Equivalent

510(k) numberK090954

Submission

Device name
Atlas Wound Matrix
Applicant
Wrightmedicaltechnologyinc
Arlington, TN, US
Received
April 6, 2009
Decision date
July 30, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KGN – Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Implant
Yes

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Questions and answers

When was Atlas Wound Matrix cleared by the FDA?

Atlas Wound Matrix (K090954) received a 510(k) decision of Substantially Equivalent on July 30, 2009, 115 days after the submission was received.

What is the product code of K090954?

The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.