Cleared Traditional

IB3D ALIF

K191134 · Medicrea International SA · Orthopedic

Oct 2019

Decision

184d

Days

Class 2

Risk

About This 510(k) Submission

K191134 is an FDA 510(k) clearance for the IB3D ALIF, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medicrea International SA (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on October 30, 2019, 184 days after receiving the submission on April 29, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K191134 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2019
Decision Date	October 30, 2019
Days to Decision	184 days
Submission Type	Traditional
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.