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FDA 510(k)

HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture

K-Number: K203794 · 2021-02-01

ApplicantMedos International SARL
Decision Date2021-02-01
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2021-02-01 under approval number K203794. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture?

HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture is a medical device that received FDA 510(k) clearance on 2021-02-01. It is manufactured by Medos International SARL. The 510(k) number is K203794.

When was HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture approved by the FDA?

HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture received FDA 510(k) clearance on 2021-02-01, under approval number K203794.

What company makes HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture?

HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture is manufactured by Medos International SARL.

What is the FDA product code for HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture?

The FDA product code for HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture is MBI.

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)

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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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