Cleared Traditional

Zavation IBF

K162206 · Zavation, LLC · Orthopedic

Apr 2017

Decision

242d

Days

Class 2

Risk

About This 510(k) Submission

K162206 is an FDA 510(k) clearance for the Zavation IBF, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Zavation, LLC (Flowood, US). The FDA issued a Cleared decision on April 4, 2017, 242 days after receiving the submission on August 5, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K162206 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2016
Decision Date	April 04, 2017
Days to Decision	242 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.