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FDA 510(k)

Helios Dura Regeneration Matrix

K-Number: K250420 · 2025-05-14

ApplicantHelios Biomedical, Inc.
Decision Date2025-05-14
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Helios Dura Regeneration Matrix is a medical device manufactured by Helios Biomedical, Inc.. It received FDA 510(k) clearance on 2025-05-14 under approval number K250420. 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 Helios Dura Regeneration Matrix?

Helios Dura Regeneration Matrix is a medical device that received FDA 510(k) clearance on 2025-05-14. It is manufactured by Helios Biomedical, Inc.. The 510(k) number is K250420.

When was Helios Dura Regeneration Matrix approved by the FDA?

Helios Dura Regeneration Matrix received FDA 510(k) clearance on 2025-05-14, under approval number K250420.

What company makes Helios Dura Regeneration Matrix?

Helios Dura Regeneration Matrix is manufactured by Helios Biomedical, Inc..

What is the FDA product code for Helios Dura Regeneration Matrix?

The FDA product code for Helios Dura 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

Other Devices by Helios Biomedical, Inc.

K250397Helios Dermal Scaffold

Related Devices (Code: GXQ)

K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery K161278Cerafix Dura SubstituteAcera Surgical, Inc. K153613Cerafix Dura SubstituteAcera Surgical, Inc. K172603Cerafix Dura SubstituteAcera Surgical, Inc. K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.

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.

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