Suzhou Microport Orthorecon Co., Ltd. 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
EVOLUTION MPX Total Knee System510(k)Sep 10, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 10, 2026
MedalOne Total Knee System510(k)Feb 28, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 28, 2025