Cleared Traditional

Centerpiece Plate Fixation System

K212428 · Medtronic Sofamor Danek · Orthopedic

Dec 2021

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K212428 is an FDA 510(k) clearance for the Centerpiece Plate Fixation System, a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II — Special Controls, product code NQW), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on December 13, 2021, 131 days after receiving the submission on August 4, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K212428 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2021
Decision Date	December 13, 2021
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NQW — Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3050
Definition	This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.