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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 the device name listed in this FDA 510(k) record. The listed applicant is Acera Surgical, Inc.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) 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. The listed applicant is Acera Surgical, Inc.. The 510(k) number is K251224.

When did Restrata Soft Tissue Reinforcement (STR) receive FDA 510(k) clearance?

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

Who is the listed applicant for Restrata Soft Tissue Reinforcement (STR)?

The FDA 510(k) record lists Acera Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06578650A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous NeoplasmsRECRUITING

Other records listing Acera Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223725Restrata® MiniMatrixK193583Restrata®K172603Cerafix Dura SubstituteK170300Restrata Wound MatrixK161278Cerafix Dura SubstituteK153613Cerafix Dura Substitute

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Related Devices (Code: OXF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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