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FDA 510(k)

HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)

K-Number: K131974 · 2013-07-25

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2013-07-25
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) 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 2013-07-25 under 510(k) number K131974. 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 KNOTLESS BR ANCHOR (6.5MM)?

HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) is a medical device that received FDA 510(k) clearance on 2013-07-25. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K131974.

When did HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) receive FDA 510(k) clearance?

HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) received FDA 510(k) clearance on 2013-07-25, under 510(k) number K131974.

Who is the listed applicant for HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)?

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 ADVANCE KNOTLESS BR ANCHOR (6.5MM)?

The FDA product code for HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) is MAI.

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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.

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, 55MMK1311914MM & 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 ANCHORK130539HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)

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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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