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FDA 510(k)

HEALIX ADVANCE BR ANCHOR

K-Number: K120078 · 2012-02-29

ApplicantDepuy Mitek Inc., Johnson and Johnson Company
Decision Date2012-02-29
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE BR ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek Inc., Johnson and Johnson Company. It received FDA 510(k) clearance on 2012-02-29 under 510(k) number K120078. 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 BR ANCHOR?

HEALIX ADVANCE BR ANCHOR is a medical device that received FDA 510(k) clearance on 2012-02-29. The listed applicant is Depuy Mitek Inc., Johnson and Johnson Company. The 510(k) number is K120078.

When did HEALIX ADVANCE BR ANCHOR receive FDA 510(k) clearance?

HEALIX ADVANCE BR ANCHOR received FDA 510(k) clearance on 2012-02-29, under 510(k) number K120078.

Who is the listed applicant for HEALIX ADVANCE BR ANCHOR?

The FDA 510(k) record lists Depuy Mitek Inc., Johnson and Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALIX ADVANCE BR ANCHOR?

The FDA product code for HEALIX ADVANCE BR ANCHOR is MAI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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