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FDA 510(k)

HEALIX ADVANCE KNOTLESS Anchor

K-Number: K171114 · 2017-11-27

ApplicantMedos International SARL
Decision Date2017-11-27
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE KNOTLESS Anchor is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2017-11-27 under approval number K171114. 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 HEALIX ADVANCE KNOTLESS Anchor?

HEALIX ADVANCE KNOTLESS Anchor is a medical device that received FDA 510(k) clearance on 2017-11-27. It is manufactured by Medos International SARL. The 510(k) number is K171114.

When was HEALIX ADVANCE KNOTLESS Anchor approved by the FDA?

HEALIX ADVANCE KNOTLESS Anchor received FDA 510(k) clearance on 2017-11-27, under approval number K171114.

What company makes HEALIX ADVANCE KNOTLESS Anchor?

HEALIX ADVANCE KNOTLESS Anchor is manufactured by Medos International SARL.

What is the FDA product code for HEALIX ADVANCE KNOTLESS Anchor?

The FDA product code for HEALIX ADVANCE KNOTLESS Anchor is MAI.

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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 K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.

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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