Promethean Restorative, LLC 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
DYNAMIS Navigation System510(k)Jan 12, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 12, 2026
DYNAMIS Implant System510(k)Apr 25, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 25, 2025
DYNAMIS SI Screw System510(k)Feb 28, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 28, 2025