Amplify Surgical, Inc. 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
DualXSLIM(R) T/PLIF510(k)Oct 18, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 18, 2022
DualX510(k)Sep 29, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 29, 2021