Cleared Special

FUSE Spinal System

K171468 · Medtronic Sofamor Danek · Orthopedic

Jun 2017

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K171468 is an FDA 510(k) clearance for the FUSE 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 June 13, 2017, 26 days after receiving the submission on May 18, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K171468 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2017
Decision Date	June 13, 2017
Days to Decision	26 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.