DuraGen Secure Dural Regeneration Matrix
FDA 510(k) K163456 · Integra LifeSciences Corporation
510(k) numberK163456
Submission
- Device name
- DuraGen Secure Dural Regeneration Matrix
- Applicant
- Integra LifeSciences Corporation
Planisboro, NJ, US - Received
- December 9, 2016
- Decision date
- January 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - RepairGXQ · Traditional | Collagen Matrix, Inc. | 11/18/2025SE |
| K250420 | Helios Dura Regeneration MatrixGXQ · Traditional | Helios Biomedical, Inc. | 05/14/2025SE |
| K223445 | ArtiFasciaGXQ · Traditional | Nurami Medical , Ltd. | 08/10/2023SE |
| K212943 | SyntheCel Dura RepairGXQ · Traditional | Synthes (USA) Products, LLC | 01/28/2022SE |
| K183513 | XenoSure Dura Biologic PatchGXQ · Traditional | LeMaitre Vascular, Inc. | 06/13/2019SE |
| K172603 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 11/27/2017SE |
| K161370 | Durepair Dura Regeneration MatrixGXQ · Traditional | Medtronic Neurosurgery | 11/02/2016SE |
| K161278 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 08/08/2016SE |
| K153613 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 03/16/2016SE |
| K150825 | Collagen Dural Regeneration MatrixGXQ · Traditional | Collagen Matrix, Inc. | 11/20/2015SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 10/08/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | 04/09/2025SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2023SE |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 08/22/2022SE |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Special | 07/15/2022SE |
| K210128 | INTEGRA Wound Matrix (Macro-Channels)KGN · Traditional | 10/08/2021SE |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…HRS · Traditional | 07/27/2021SE |
| K193346 | Codman Surgical Patties & StripsHBA · Traditional | 11/20/2020SE |
| K201507 | Cadence Total Ankle SystemHSN · Special | 06/29/2020SE |
Questions and answers
When was DuraGen Secure Dural Regeneration Matrix cleared by the FDA?
DuraGen Secure Dural Regeneration Matrix (K163456) received a 510(k) decision of Substantially Equivalent on January 6, 2017, 28 days after the submission was received.
What is the product code of K163456?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.