Cleared Traditional

Dakota ALIF System

K213118 · Precision Spine, Inc. · Orthopedic

Apr 2022

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K213118 is an FDA 510(k) clearance for the Dakota ALIF System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on April 1, 2022, 186 days after receiving the submission on September 27, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K213118 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2021
Decision Date	April 01, 2022
Days to Decision	186 days
Submission Type	Traditional
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.