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FDA 510(k)

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw

K-Number: K240441 · 2024-03-15

ApplicantDepuy Mitek
Decision Date2024-03-15
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K240441. 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 MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw?

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Depuy Mitek. The 510(k) number is K240441.

When did MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw receive FDA 510(k) clearance?

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw received FDA 510(k) clearance on 2024-03-15, under 510(k) number K240441.

Who is the listed applicant for MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw?

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

What is the FDA product code for MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw?

The FDA product code for MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw 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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