Cleared Special

Align

K222561 · Acuity Surgical Devices, LLC · Orthopedic

Sep 2022

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K222561 is an FDA 510(k) clearance for the Align, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Acuity Surgical Devices, LLC (Irving, US). The FDA issued a Cleared decision on September 23, 2022, 30 days after receiving the submission on August 24, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K222561 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2022
Decision Date	September 23, 2022
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.