Cleared Traditional

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device

K153373 · Medtronic Sofamor Danek · Orthopedic

Jan 2016

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K153373 is an FDA 510(k) clearance for the CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody 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 January 19, 2016, 57 days after receiving the submission on November 23, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K153373 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2015
Decision Date	January 19, 2016
Days to Decision	57 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.