Cleared Traditional

Align Cervical Interbody Fusion System

K230639 · Acuity Surgical Devices, LLC · Orthopedic

Dec 2023

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K230639 is an FDA 510(k) clearance for the Align Cervical Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Acuity Surgical Devices, LLC (Irving, US). The FDA issued a Cleared decision on December 1, 2023, 268 days after receiving the submission on March 8, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K230639 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2023
Decision Date	December 01, 2023
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.