Cleared Traditional

IMPIX ALIF S/A

K141187 · Medicrea International SA · Orthopedic

Jan 2015

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K141187 is an FDA 510(k) clearance for the IMPIX ALIF S/A, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Medicrea International SA (Neyron, FR). The FDA issued a Cleared decision on January 15, 2015, 252 days after receiving the submission on May 8, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K141187 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2014
Decision Date	January 15, 2015
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.