Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DuraGen Secure Dural Regeneration Matrix

K-Number: K163456 · 2017-01-06

ApplicantIntegra LifeSciences Corporation
Decision Date2017-01-06
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DuraGen Secure Dural Regeneration Matrix is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2017-01-06 under approval number K163456. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DuraGen Secure Dural Regeneration Matrix?

DuraGen Secure Dural Regeneration Matrix is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K163456.

When was DuraGen Secure Dural Regeneration Matrix approved by the FDA?

DuraGen Secure Dural Regeneration Matrix received FDA 510(k) clearance on 2017-01-06, under approval number K163456.

What company makes DuraGen Secure Dural Regeneration Matrix?

DuraGen Secure Dural Regeneration Matrix is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for DuraGen Secure Dural Regeneration Matrix?

The FDA product code for DuraGen Secure Dural Regeneration Matrix is GXQ.

Related Clinical Trials

NCT03164122 EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA COMPLETED NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT06857708 The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix® RECRUITING

Other Devices by Integra LifeSciences Corporation

K160811CRW STEREOTACTIC SYSTEM K161882CUSA Clarity Ultrasonic Surgical Aspirator System K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems K161189Integra TITAN Reverse Shoulder System K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory

View all 32 devices →

Related Devices (Code: GXQ)

K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery K161278Cerafix Dura SubstituteAcera Surgical, Inc. K153613Cerafix Dura SubstituteAcera Surgical, Inc. K172603Cerafix Dura SubstituteAcera Surgical, Inc. K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc. K212943SyntheCel Dura RepairSynthes (USA) Products, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑