Auxano Medical, LLC FDA Approvals

0 new drug approvals and 2 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
Auxano® Wedge Fixation System510(k)Sep 25, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 25, 2025
Intraosseous Fusion Device System510(k)Sep 29, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 29, 2023