Depuy Mitek FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
GRYPHON X Anchor; HEALIX TRANSTEND Anchor510(k)Feb 5, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 5, 2025
HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors510(k)Sep 11, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 11, 2024
MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw510(k)Mar 15, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 15, 2024