Cleared Traditional

K131077 - LIFE SPINE PLATEAU SPACER SYSTEM
(FDA 510(k) Clearance)

K131077 · Life Spine · Orthopedic

Jul 2013

Decision

91d

Days

Class 2

Risk

K131077 is an FDA 510(k) clearance for the LIFE SPINE PLATEAU SPACER SYSTEM. This device is classified as a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX).

Submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on July 17, 2013, 91 days after receiving the submission on April 17, 2013.

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	K131077 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2013
Decision Date	July 17, 2013
Days to Decision	91 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.