Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. FDA Approvals

0 new drug approvals and 4 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
Internal Locking Plate and Screw Fixation System510(k)Dec 15, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 15, 2023
SGM Femoral Nail System510(k)Jun 30, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 30, 2023
PEEK Spinal Infusion Cage510(k)Mar 3, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 3, 2023
Spinal Inner Fixation System510(k)Oct 28, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 28, 2022