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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 the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2017-05-18 under 510(k) 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. The listed applicant is Medos International SARL. The 510(k) number is K170639.

When did HEALIX ADVANCE Anchor with PERMATAPE Suture receive FDA 510(k) clearance?

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

Who is the listed applicant for HEALIX ADVANCE Anchor with PERMATAPE Suture?

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 ADVANCE Anchor with PERMATAPE Suture?

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