FDA 510(k)

GRYPHON X Anchor; HEALIX TRANSTEND Anchor

K-Number: K243790 · 2025-02-05

Decision Date2025-02-05

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GRYPHON X Anchor; HEALIX TRANSTEND Anchor is a medical device manufactured by Depuy Mitek. It received FDA 510(k) clearance on 2025-02-05 under approval number K243790. 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 GRYPHON X Anchor; HEALIX TRANSTEND Anchor?

GRYPHON X Anchor; HEALIX TRANSTEND Anchor is a medical device that received FDA 510(k) clearance on 2025-02-05. It is manufactured by Depuy Mitek. The 510(k) number is K243790.

When was GRYPHON X Anchor; HEALIX TRANSTEND Anchor approved by the FDA?

GRYPHON X Anchor; HEALIX TRANSTEND Anchor received FDA 510(k) clearance on 2025-02-05, under approval number K243790.

What company makes GRYPHON X Anchor; HEALIX TRANSTEND Anchor?

GRYPHON X Anchor; HEALIX TRANSTEND Anchor is manufactured by Depuy Mitek.

What is the FDA product code for GRYPHON X Anchor; HEALIX TRANSTEND Anchor?

The FDA product code for GRYPHON X Anchor; HEALIX TRANSTEND Anchor is MAI.

Other Devices by Depuy Mitek

K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw

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.