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FDA 510(k)

HEALIX ADVANCE Anchor with PERMATAPE Suture

K-Number: K170639 · 2017-05-18

ApplicantMedos International SARL
Decision Date2017-05-18
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE Anchor with PERMATAPE Suture is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2017-05-18 under approval number K170639. 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 Anchor with PERMATAPE Suture?

HEALIX ADVANCE Anchor with PERMATAPE Suture is a medical device that received FDA 510(k) clearance on 2017-05-18. It is manufactured by Medos International SARL. The 510(k) number is K170639.

When was HEALIX ADVANCE Anchor with PERMATAPE Suture approved by the FDA?

HEALIX ADVANCE Anchor with PERMATAPE Suture received FDA 510(k) clearance on 2017-05-18, under approval number K170639.

What company makes HEALIX ADVANCE Anchor with PERMATAPE Suture?

HEALIX ADVANCE Anchor with PERMATAPE Suture is manufactured by Medos International SARL.

What is the FDA product code for HEALIX ADVANCE Anchor with PERMATAPE Suture?

The FDA product code for HEALIX ADVANCE Anchor with PERMATAPE Suture is MAI.

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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Related Devices (Code: MAI)

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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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