Acuity Surgical Devices, LLC FDA Approvals

0 new drug approvals and 8 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
Stabilis SA Cervical Stand-Alone System (Various PNs)510(k)Jul 30, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 30, 2025
Tera Lumbar Interbody Fusion System (Various PNs)510(k)Jun 2, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 2, 2025
Ventris Intervertebral Body Fusion Device510(k)Apr 22, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 22, 2025
sagAlign Lumbar Cage System (Various PNs)510(k)Jul 17, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 17, 2024
Align Cervical Interbody Fusion System510(k)Dec 1, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 1, 2023
Align510(k)Sep 23, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 23, 2022
Align Lumbar Interbody Fusion System510(k)Jul 22, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 22, 2022
A-Link Z510(k)May 4, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 4, 2021