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FDA 510(k)

GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..

K-Number: K111631 · 2011-07-22

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2011-07-22
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2011-07-22 under 510(k) number K111631. 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 GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..?

GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. is a medical device that received FDA 510(k) clearance on 2011-07-22. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K111631.

When did GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. receive FDA 510(k) clearance?

GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. received FDA 510(k) clearance on 2011-07-22, under 510(k) number K111631.

Who is the listed applicant for GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..?

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

What is the FDA product code for GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..?

The FDA product code for GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. is MBI.

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Other records listing Depuy Mitek, A Johnson & Johnson Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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