Cleared Special

PERIMETER INTERBODY FUSION DEVICE

K111525 · Medtronic Sofamor Danek · Orthopedic

Aug 2011

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K111525 is an FDA 510(k) clearance for the PERIMETER INTERBODY FUSION DEVICE, 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 August 24, 2011, 84 days after receiving the submission on June 1, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K111525 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2011
Decision Date	August 24, 2011
Days to Decision	84 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.