Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Depuy Mitek. It received FDA 510(k) clearance on 2024-03-15 under approval 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. It is manufactured by Depuy Mitek. The 510(k) number is K240441.

When was MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw approved by the FDA?

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

What company makes MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw?

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw is manufactured by Depuy Mitek.

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.

Other Devices by Depuy Mitek

K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor

Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation

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.

↑