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Spineart SA FDA Approvals

0 new drug approvals and 13 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
SCALA® TL510(k)Aug 20, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 20, 2026
BAGUERA® C Cervical Disc Surgical Instruments510(k)Aug 14, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 14, 2026
SPINEART Navigation Instrument System510(k)Jul 29, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System510(k)May 1, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 1, 2026
SPINEART Navigation Instrument System510(k)Apr 9, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Apr 9, 2026
SPINEART Navigation Instrument System510(k)Jun 18, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 18, 2025
SPINEART Navigation Instrument System510(k)Mar 7, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 7, 2025
Scarlet® AL-T510(k)Oct 23, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 23, 2024
SPINEART Navigation Instrument System510(k)Aug 7, 2024Neurology	Neurology	510(k)Substantially Equivalent (Special)	Aug 7, 2024
Juliet® Ti LL Lumbar Interbody Device510(k)Jul 18, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 18, 2024
SCARLET® AC-Ti510(k)May 10, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 10, 2024
PERLA® TL Posterior Thoraco-lumbar Fixation System510(k)Oct 25, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 25, 2023
Tryptik Ti510(k)Mar 22, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 22, 2023

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