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FDA 510(k)

HEALIX ADVANCE SP BIOCOMPOSITE Anchor

K-Number: K191242 · 2019-08-22

ApplicantMedos International SARL
Decision Date2019-08-22
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE SP BIOCOMPOSITE Anchor is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2019-08-22 under approval number K191242. 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 SP BIOCOMPOSITE Anchor?

HEALIX ADVANCE SP BIOCOMPOSITE Anchor is a medical device that received FDA 510(k) clearance on 2019-08-22. It is manufactured by Medos International SARL. The 510(k) number is K191242.

When was HEALIX ADVANCE SP BIOCOMPOSITE Anchor approved by the FDA?

HEALIX ADVANCE SP BIOCOMPOSITE Anchor received FDA 510(k) clearance on 2019-08-22, under approval number K191242.

What company makes HEALIX ADVANCE SP BIOCOMPOSITE Anchor?

HEALIX ADVANCE SP BIOCOMPOSITE Anchor is manufactured by Medos International SARL.

What is the FDA product code for HEALIX ADVANCE SP BIOCOMPOSITE Anchor?

The FDA product code for HEALIX ADVANCE SP BIOCOMPOSITE Anchor 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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