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FDA 510(k)

ArtiFascia

K-Number: K223445 · 2023-08-10

ApplicantNurami Medical , Ltd.
Decision Date2023-08-10
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ArtiFascia is the device name listed in this FDA 510(k) record. The listed applicant is Nurami Medical , Ltd.. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K223445. 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 ArtiFascia?

ArtiFascia is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Nurami Medical , Ltd.. The 510(k) number is K223445.

When did ArtiFascia receive FDA 510(k) clearance?

ArtiFascia received FDA 510(k) clearance on 2023-08-10, under 510(k) number K223445.

Who is the listed applicant for ArtiFascia?

The FDA 510(k) record lists Nurami Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArtiFascia?

The FDA product code for ArtiFascia is GXQ.

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.

NCT07765862A PROSPECTIVE, RANDOMIZED, TWO-ARM, CONTROLLED, SINGLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ARTIFIX® DURAL REPAIR SEALANT GRAFT IN CRANIAL AND SPINE SURGERY (NEOFIX STUDY)NOT_YET_RECRUITING

Related Devices (Code: GXQ)

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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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