Durepair Dura Regeneration Matrix
FDA 510(k) K161370 · Medtronic Neurosurgery
510(k) numberK161370
Submission
- Device name
- Durepair Dura Regeneration Matrix
- Applicant
- Medtronic Neurosurgery
Goleta, CA, US - Received
- May 17, 2016
- Decision date
- November 2, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K163456 | DuraGen Secure Dural Regeneration MatrixGXQ · Special | Integra LifeSciences Corporation | 01/06/2017SE |
| 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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| K212641 | StrataMR II Valves and ShuntsJXG · Special | 09/16/2021SE |
| K181622 | StrataMR guider toolJXG · Traditional | 10/01/2018SE |
| K152700 | StrataMR Valves and ShuntsJXG · Traditional | 04/07/2016SE |
| K123524 | Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | 02/13/2013SE |
| K110560 | Medtronic Ares Antibiotic-Impregnated CatheterJXG · Traditional | 11/18/2011SE |
| K091312 | PS Medical Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | 09/02/2009SE |
| K083076 | Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836JXG · Special | 11/20/2008SE |
| K082127 | Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635JXG · Special | 08/27/2008SE |
Questions and answers
When was Durepair Dura Regeneration Matrix cleared by the FDA?
Durepair Dura Regeneration Matrix (K161370) received a 510(k) decision of Substantially Equivalent on November 2, 2016, 169 days after the submission was received.
What is the product code of K161370?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.