Cleared Special

CRESCENT? Spinal System

K171031 · Medtronic Sofamor Danek · Orthopedic

Jul 2017

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K171031 is an FDA 510(k) clearance for the CRESCENT? Spinal System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on July 6, 2017, 91 days after receiving the submission on April 6, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K171031 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2017
Decision Date	July 06, 2017
Days to Decision	91 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.