Cleared Traditional

Zavation Posterior LEIF

K142392 · Zavation, LLC · Orthopedic

Apr 2015

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K142392 is an FDA 510(k) clearance for the Zavation Posterior LEIF, 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 29, 2015, 245 days after receiving the submission on August 27, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K142392 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2014
Decision Date	April 29, 2015
Days to Decision	245 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.