Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEALIX ADVANCE KNOTLESS BR Anchor

K-Number: K180101 · 2018-05-10

ApplicantMedos International SARL
Decision Date2018-05-10
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE KNOTLESS BR Anchor is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2018-05-10 under approval number K180101. 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 BR Anchor?

HEALIX ADVANCE KNOTLESS BR Anchor is a medical device that received FDA 510(k) clearance on 2018-05-10. It is manufactured by Medos International SARL. The 510(k) number is K180101.

When was HEALIX ADVANCE KNOTLESS BR Anchor approved by the FDA?

HEALIX ADVANCE KNOTLESS BR Anchor received FDA 510(k) clearance on 2018-05-10, under approval number K180101.

What company makes HEALIX ADVANCE KNOTLESS BR Anchor?

HEALIX ADVANCE KNOTLESS BR Anchor is manufactured by Medos International SARL.

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

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

Other Devices by Medos International SARL

K162247PERMATAPE K162327COUGAR® LS Lateral Cage System and COUGAR® System K162912VIPER PRIME™ additions to the VIPER® System K163106CODMAN Integrated Bipolar Cord and Tubing Set K161638SPEEDTRAP Graft Preparation System K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps

View all 73 devices →

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.

↑