Cleared Special

K120576 - ZAVATION IBF SYSTEM
(FDA 510(k) Clearance)

K120576 · Zavation, LLC · Orthopedic

Mar 2012

Decision

30d

Days

Class 2

Risk

K120576 is an FDA 510(k) clearance for the ZAVATION IBF SYSTEM. This device is classified as a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX).

Submitted by Zavation, LLC (Brandon, US). The FDA issued a Cleared decision on March 28, 2012, 30 days after receiving the submission on February 27, 2012.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..

Submission Details

510(k) Number	K120576 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2012
Decision Date	March 28, 2012
Days to Decision	30 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.