Spineart 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
PERLA® TL System; TEKTONA® HV US Bone Cement510(k)Jun 23, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 23, 2023
PERLA® TL Posterior Osteosynthesis System510(k)Jan 21, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 21, 2022
SPINEART Navigation Instrument System510(k)Mar 19, 2021Neurology	Neurology	510(k)Substantially Equivalent (Special)	Mar 19, 2021
PERLA® TL posterior osteosynthesis system510(k)Jan 15, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 15, 2021