FDA 510(k)

Cerafix Dura Substitute

K-Number: K161278 · 2016-08-08

Decision Date2016-08-08

Product CodeGXQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Cerafix Dura Substitute is a medical device manufactured by Acera Surgical, Inc.. It received FDA 510(k) clearance on 2016-08-08 under approval number K161278. 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 Cerafix Dura Substitute?

Cerafix Dura Substitute is a medical device that received FDA 510(k) clearance on 2016-08-08. It is manufactured by Acera Surgical, Inc.. The 510(k) number is K161278.

When was Cerafix Dura Substitute approved by the FDA?

Cerafix Dura Substitute received FDA 510(k) clearance on 2016-08-08, under approval number K161278.

What company makes Cerafix Dura Substitute?

Cerafix Dura Substitute is manufactured by Acera Surgical, Inc..

What is the FDA product code for Cerafix Dura Substitute?

The FDA product code for Cerafix Dura Substitute is GXQ.

Other Devices by Acera Surgical, Inc.

K153613Cerafix Dura Substitute K172603Cerafix Dura Substitute K170300Restrata Wound Matrix K193583Restrata® K223725Restrata® MiniMatrix K251224Restrata Soft Tissue Reinforcement (STR)

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Related Devices (Code: GXQ)

K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery K153613Cerafix Dura SubstituteAcera Surgical, Inc. K172603Cerafix Dura SubstituteAcera Surgical, Inc. K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc. K212943SyntheCel Dura RepairSynthes (USA) Products, LLC

Official Source

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