Cleared Special

SOVEREIGN SPINAL SYSTEM

K121982 · Medtronic Sofamor Danek · Orthopedic

Jul 2012

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K121982 is an FDA 510(k) clearance for the SOVEREIGN SPINAL SYSTEM, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on July 26, 2012, 20 days after receiving the submission on July 6, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K121982 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2012
Decision Date	July 26, 2012
Days to Decision	20 days
Submission Type	Special
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.