Cleared Traditional

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System

K203129 · Precision Spine, Inc. · Orthopedic

Jan 2021

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K203129 is an FDA 510(k) clearance for the NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on January 12, 2021, 85 days after receiving the submission on October 19, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K203129 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 2020
Decision Date	January 12, 2021
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.