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FDA 510(k)

HEALIX ADVANCE Anchor with DYNACORD Suture

K-Number: K183506 · 2019-02-14

ApplicantMedos International SARL
Decision Date2019-02-14
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE Anchor with DYNACORD Suture is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2019-02-14 under approval number K183506. 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 DYNACORD Suture?

HEALIX ADVANCE Anchor with DYNACORD Suture is a medical device that received FDA 510(k) clearance on 2019-02-14. It is manufactured by Medos International SARL. The 510(k) number is K183506.

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

HEALIX ADVANCE Anchor with DYNACORD Suture received FDA 510(k) clearance on 2019-02-14, under approval number K183506.

What company makes HEALIX ADVANCE Anchor with DYNACORD Suture?

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

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

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

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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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