FDA 510(k)

Fixone hybrid knotless anchor

K-Number: K203523 · 2021-12-25

Decision Date2021-12-25

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Fixone hybrid knotless anchor is a medical device manufactured by Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2021-12-25 under approval number K203523. 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 Fixone hybrid knotless anchor?

Fixone hybrid knotless anchor is a medical device that received FDA 510(k) clearance on 2021-12-25. It is manufactured by Aju Pharm Co., Ltd.. The 510(k) number is K203523.

When was Fixone hybrid knotless anchor approved by the FDA?

Fixone hybrid knotless anchor received FDA 510(k) clearance on 2021-12-25, under approval number K203523.

What company makes Fixone hybrid knotless anchor?

Fixone hybrid knotless anchor is manufactured by Aju Pharm Co., Ltd..

What is the FDA product code for Fixone hybrid knotless anchor?

The FDA product code for Fixone hybrid knotless anchor is MAI.

Other Devices by Aju Pharm Co., Ltd.

K171299Fixone Biocomposite Anchor K162070JOINIX CANNULAR SYSTEM K192709Fixone All Suture Anchor K192484Fixone Biocomposite Anchor K192032Fixone Biocomposite Small Anchor K193497Fixone Biocomposite Interference Screw

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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.