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FDA 510(k)

Restrata Wound Matrix

K-Number: K170300 · 2017-04-26

ApplicantAcera Surgical, Inc.
Decision Date2017-04-26
Product CodeQSZ
DecisionSubstantially Equivalent

Device Summary

Restrata Wound Matrix is a medical device manufactured by Acera Surgical, Inc.. It received FDA 510(k) clearance on 2017-04-26 under approval number K170300. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Restrata Wound Matrix?

Restrata Wound Matrix is a medical device that received FDA 510(k) clearance on 2017-04-26. It is manufactured by Acera Surgical, Inc.. The 510(k) number is K170300.

When was Restrata Wound Matrix approved by the FDA?

Restrata Wound Matrix received FDA 510(k) clearance on 2017-04-26, under approval number K170300.

What company makes Restrata Wound Matrix?

Restrata Wound Matrix is manufactured by Acera Surgical, Inc..

What is the FDA product code for Restrata Wound Matrix?

The FDA product code for Restrata Wound Matrix is QSZ.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT06073808 The Role of Amnion Membrane Allografts in Nipple Preservation NOT_YET_RECRUITING NCT06919809 Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery 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 Acera Surgical, Inc.

K161278Cerafix Dura Substitute K153613Cerafix Dura Substitute K172603Cerafix Dura Substitute K193583Restrata® K223725Restrata® MiniMatrix K251224Restrata Soft Tissue Reinforcement (STR)

View all 7 devices →

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 K173544Phoenix Wound MatrixNanofiber Solutions, Inc. K193583Restrata®Acera Surgical, Inc. K222189SiOxD Wound MatrixSioxmed, 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.

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