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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 a medical device manufactured by Acuitive Technologies, Inc.. It received FDA 510(k) clearance on 2021-02-05 under approval 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. It is manufactured by Acuitive Technologies, Inc.. The 510(k) number is K203334.

When was The Citrefix Knotless Suture Anchor approved by the FDA?

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

What company makes The Citrefix Knotless Suture Anchor?

The Citrefix Knotless Suture Anchor is manufactured by Acuitive Technologies, Inc..

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

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

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Acuitive Technologies, Inc.

K210239CITRESPLINE and CITRELOCK ACL Implants K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL K232592CITRELOCK® DUO K221468Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants K240450Citrepore™

Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed 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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