Medtronic Sofamor Danek, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. Matched by name to MDT.

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
Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft510(k)Jun 12, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 12, 2025
Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules510(k)Jan 17, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 17, 2025
Robotic Graft Delivery Instruments510(k)Jul 18, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 18, 2023