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FDA 510(k)

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors

K-Number: K241010 · 2024-09-11

ApplicantDepuy Mitek
Decision Date2024-09-11
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors is a medical device manufactured by Depuy Mitek. It received FDA 510(k) clearance on 2024-09-11 under approval number K241010. 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 anchors; HEALIX ADVANCE Self-Punching anchors?

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors is a medical device that received FDA 510(k) clearance on 2024-09-11. It is manufactured by Depuy Mitek. The 510(k) number is K241010.

When was HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors approved by the FDA?

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors received FDA 510(k) clearance on 2024-09-11, under approval number K241010.

What company makes HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors?

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors is manufactured by Depuy Mitek.

What is the FDA product code for HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors?

The FDA product code for HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors is MAI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED

Other Devices by Depuy Mitek

K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor

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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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