Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal Mend Dural Regeneration Matrix, Mo

FDA 510(k) K092388 · Integra LifeSciences Corporation

Substantially Equivalent

510(k) numberK092388

Submission

Device name
Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal Mend Dural Regeneration Matrix, Mo
Applicant
Integra LifeSciences Corporation
Planisboro, NJ, US
Received
August 5, 2009
Decision date
January 21, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXQ – Dura Substitute
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5910
Specialty
Neurology
Implant
Yes

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K223445ArtiFasciaGXQ · Traditional Nurami Medical , Ltd.08/10/2023SE
K212943SyntheCel Dura RepairGXQ · Traditional Synthes (USA) Products, LLC01/28/2022SE
K183513XenoSure Dura Biologic PatchGXQ · Traditional LeMaitre Vascular, Inc.06/13/2019SE
K172603Cerafix Dura SubstituteGXQ · Traditional Acera Surgical, Inc.11/27/2017SE
K163456DuraGen Secure Dural Regeneration MatrixGXQ · Special Integra LifeSciences Corporation01/06/2017SE
K161370Durepair Dura Regeneration MatrixGXQ · Traditional Medtronic Neurosurgery11/02/2016SE
K161278Cerafix Dura SubstituteGXQ · Traditional Acera Surgical, Inc.08/08/2016SE
K153613Cerafix Dura SubstituteGXQ · Traditional Acera Surgical, Inc.03/16/2016SE

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Questions and answers

When was Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal Mend Dural Regeneration Matrix, Mo cleared by the FDA?

Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal Mend Dural Regeneration Matrix, Mo (K092388) received a 510(k) decision of Substantially Equivalent on January 21, 2010, 169 days after the submission was received.

What is the product code of K092388?

The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.