Foundation Surgical Group, Inc. 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
Foundation Surgical Navigated Lateral Disc Prep Instruments510(k)Apr 16, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 16, 2026
Vertiwedge® Intraosseous System510(k)Nov 7, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 7, 2024
Interwedge® Standalone Lateral510(k)Oct 2, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 2, 2024