Cleared Traditional

CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE

K100214 · Medtronic Sofamor Danek · Orthopedic

Jun 2010

Decision

151d

Days

Class 2

Risk

About This 510(k) Submission

K100214 is an FDA 510(k) clearance for the CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on June 25, 2010, 151 days after receiving the submission on January 25, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K100214 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2010
Decision Date	June 25, 2010
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, 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.