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FDA 510(k)

Restrata Soft Tissue Reinforcement (STR)

K-Number: K251224 · 2025-06-20

ApplicantAcera Surgical, Inc.
Decision Date2025-06-20
Product CodeOXF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Restrata Soft Tissue Reinforcement (STR) is a medical device manufactured by Acera Surgical, Inc.. It received FDA 510(k) clearance on 2025-06-20 under approval number K251224. The device is classified under product code OXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Restrata Soft Tissue Reinforcement (STR)?

Restrata Soft Tissue Reinforcement (STR) is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Acera Surgical, Inc.. The 510(k) number is K251224.

When was Restrata Soft Tissue Reinforcement (STR) approved by the FDA?

Restrata Soft Tissue Reinforcement (STR) received FDA 510(k) clearance on 2025-06-20, under approval number K251224.

What company makes Restrata Soft Tissue Reinforcement (STR)?

Restrata Soft Tissue Reinforcement (STR) is manufactured by Acera Surgical, Inc..

What is the FDA product code for Restrata Soft Tissue Reinforcement (STR)?

The FDA product code for Restrata Soft Tissue Reinforcement (STR) is OXF.

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Other Devices by Acera Surgical, Inc.

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Related Devices (Code: OXF)

K172545SERI ContourSofregen Medical, Inc. K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. K2326023DMatrix Surgical MeshPrintbio, Inc. K2433023DMatrix DynaFlex (DynaFlex)Printbio, 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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