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FDA 510(k)

HEALIX Ti ANCHOR with DYNACORD

K-Number: K183279 · 2019-02-21

ApplicantMedos International SARL
Decision Date2019-02-21
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX Ti ANCHOR with DYNACORD is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2019-02-21 under 510(k) number K183279. 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 ANCHOR with DYNACORD?

HEALIX Ti ANCHOR with DYNACORD is a medical device that received FDA 510(k) clearance on 2019-02-21. The listed applicant is Medos International SARL. The 510(k) number is K183279.

When did HEALIX Ti ANCHOR with DYNACORD receive FDA 510(k) clearance?

HEALIX Ti ANCHOR with DYNACORD received FDA 510(k) clearance on 2019-02-21, under 510(k) number K183279.

Who is the listed applicant for HEALIX Ti ANCHOR with DYNACORD?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALIX Ti ANCHOR with DYNACORD?

The FDA product code for HEALIX Ti ANCHOR with DYNACORD is MBI.

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Related Devices (Code: MBI)

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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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