Integra LifeSciences Corporation FDA Approvals

0 new drug approvals and 8 device clearances on file. Matched by name to IART.

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
CUSA® Clarity Ultrasonic Surgical Aspirator System510(k)Oct 8, 2025	—	510(k)Substantially Equivalent (Traditional)	Oct 8, 2025
AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)510(k)Apr 9, 2025Neurology	Neurology	510(k)Substantially Equivalent (Special)	Apr 9, 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System510(k)Jul 11, 2024	—	510(k)Substantially Equivalent (Traditional)	Jul 11, 2024
CUSA Clarity Ultrasonic Surgical Aspirator System510(k)Jul 11, 2023	—	510(k)Substantially Equivalent (Traditional)	Jul 11, 2023
CUSA Clarity Ultrasonic Surgical Aspirator System510(k)Aug 22, 2022	—	510(k)Substantially Equivalent (Traditional)	Aug 22, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System510(k)Jul 15, 2022	—	510(k)Substantially Equivalent (Special)	Jul 15, 2022
INTEGRA Wound Matrix (Macro-Channels)510(k)Oct 8, 2021	—	510(k)Substantially Equivalent (Traditional)	Oct 8, 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System510(k)Jul 27, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 27, 2021