Cleared Traditional

Standalone ALIF Interbody Fusion System

K221936 · Eminent Spine · Orthopedic

Oct 2022

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K221936 is an FDA 510(k) clearance for the Standalone ALIF Interbody Fusion System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Eminent Spine (Plano, US). The FDA issued a Cleared decision on October 17, 2022, 108 days after receiving the submission on July 1, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K221936 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2022
Decision Date	October 17, 2022
Days to Decision	108 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.