Acumed, LLC FDA Approvals

0 new drug approvals and 9 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
The Acumed Wrist Fixation System - 2.4mm Screws510(k)Aug 21, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 21, 2025
The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws510(k)Jul 14, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Abbreviated)	Jul 14, 2025
The Acumed Wrist Fixation System510(k)Jun 18, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 18, 2025
Acu-Sinch Knotless Mini510(k)Jan 23, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 23, 2025
Acumed Wrist Plating System510(k)Apr 22, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 22, 2024
Acumed Acutrak 3 Headless Compression Screw System510(k)Jun 9, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 9, 2023
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional510(k)Dec 29, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 29, 2022
Acumed Ankle Syndesmosis Repair System510(k)Jan 7, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 7, 2022
Acumed Clavicle Hook Plating System510(k)Jul 15, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 15, 2021