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FDA 510(k)

The Citrefix Knotless Suture Anchor

K-Number: K203334 · 2021-02-05

ApplicantAcuitive Technologies, Inc.
Decision Date2021-02-05
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Citrefix Knotless Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Acuitive Technologies, Inc.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K203334. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Citrefix Knotless Suture Anchor?

The Citrefix Knotless Suture Anchor is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Acuitive Technologies, Inc.. The 510(k) number is K203334.

When did The Citrefix Knotless Suture Anchor receive FDA 510(k) clearance?

The Citrefix Knotless Suture Anchor received FDA 510(k) clearance on 2021-02-05, under 510(k) number K203334.

Who is the listed applicant for The Citrefix Knotless Suture Anchor?

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

What is the FDA product code for The Citrefix Knotless Suture Anchor?

The FDA product code for The Citrefix Knotless Suture Anchor is MAI.

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Related Devices (Code: MAI)

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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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