Shanghai Reach Medical Instrument Co, Ltd. FDA Approvals

0 new drug approvals and 3 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
Expandable Lumbar Fusion Cage (Type I,Type II)510(k)Nov 29, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 29, 2023
Sterile Posterior Spinal Fixation System510(k)Aug 31, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 31, 2022
Posterior Spinal Fixation System510(k)Jun 21, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 21, 2021