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FDA 510(k)

HEALIX KNOTLESS ANCHOR

K-Number: K113534 · 2011-12-20

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2011-12-20
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX KNOTLESS ANCHOR 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 2011-12-20 under 510(k) number K113534. 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 KNOTLESS ANCHOR?

HEALIX KNOTLESS ANCHOR is a medical device that received FDA 510(k) clearance on 2011-12-20. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K113534.

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

HEALIX KNOTLESS ANCHOR received FDA 510(k) clearance on 2011-12-20, under 510(k) number K113534.

Who is the listed applicant for HEALIX KNOTLESS ANCHOR?

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 HEALIX KNOTLESS ANCHOR?

The FDA product code for HEALIX KNOTLESS ANCHOR is MAI.

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

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K132241GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT TK130814RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMK131974HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)K1311914MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUSK130912OMNICUT RESECTION BLADEK130917HEALIX ADVANCE KNOTLESS BR ANCHOR

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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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