Gramercy Extremity Orthopedics, 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
GEO Extremity and Ankle Plating System510(k)Sep 21, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 21, 2021
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System510(k)Mar 26, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 26, 2021