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FDA 510(k)

Knotless SutureTak Anchors

K-Number: K180594 · 2018-06-22

ApplicantArthrex, Inc.
Decision Date2018-06-22
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Knotless SutureTak Anchors is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2018-06-22 under approval number K180594. 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 Knotless SutureTak Anchors?

Knotless SutureTak Anchors is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by Arthrex, Inc.. The 510(k) number is K180594.

When was Knotless SutureTak Anchors approved by the FDA?

Knotless SutureTak Anchors received FDA 510(k) clearance on 2018-06-22, under approval number K180594.

What company makes Knotless SutureTak Anchors?

Knotless SutureTak Anchors is manufactured by Arthrex, Inc..

What is the FDA product code for Knotless SutureTak Anchors?

The FDA product code for Knotless SutureTak Anchors is MAI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED

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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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