FDA 510(k)

SyntheCel Dura Repair

K-Number: K212943 · 2022-01-28

Decision Date2022-01-28

Product CodeGXQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SyntheCel Dura Repair is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2022-01-28 under approval number K212943. 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 SyntheCel Dura Repair?

SyntheCel Dura Repair is a medical device that received FDA 510(k) clearance on 2022-01-28. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K212943.

When was SyntheCel Dura Repair approved by the FDA?

SyntheCel Dura Repair received FDA 510(k) clearance on 2022-01-28, under approval number K212943.

What company makes SyntheCel Dura Repair?

SyntheCel Dura Repair is manufactured by Synthes (USA) Products, LLC.

What is the FDA product code for SyntheCel Dura Repair?

The FDA product code for SyntheCel Dura Repair is GXQ.

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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.