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FDA 510(k)

Restrata® MiniMatrix

K-Number: K223725 · 2023-05-18

ApplicantAcera Surgical, Inc.
Decision Date2023-05-18
Product CodeQSZ
DecisionSubstantially Equivalent

Device Summary

Restrata® MiniMatrix is a medical device manufactured by Acera Surgical, Inc.. It received FDA 510(k) clearance on 2023-05-18 under approval number K223725. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Restrata® MiniMatrix?

Restrata® MiniMatrix is a medical device that received FDA 510(k) clearance on 2023-05-18. It is manufactured by Acera Surgical, Inc.. The 510(k) number is K223725.

When was Restrata® MiniMatrix approved by the FDA?

Restrata® MiniMatrix received FDA 510(k) clearance on 2023-05-18, under approval number K223725.

What company makes Restrata® MiniMatrix?

Restrata® MiniMatrix is manufactured by Acera Surgical, Inc..

What is the FDA product code for Restrata® MiniMatrix?

The FDA product code for Restrata® MiniMatrix is QSZ.

Other Devices by Acera Surgical, Inc.

K161278Cerafix Dura Substitute K153613Cerafix Dura Substitute K172603Cerafix Dura Substitute K170300Restrata Wound Matrix K193583Restrata® K251224Restrata Soft Tissue Reinforcement (STR)

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Related Devices (Code: QSZ)

K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”Engineered Tissue Solutions, LLC K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)Polynovo Biomaterials Pty, Ltd. K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH K170300Restrata Wound MatrixAcera Surgical, Inc. K173544Phoenix Wound MatrixNanofiber Solutions, Inc. K193583Restrata®Acera Surgical, 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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