Cleared Traditional

Plateau Spacer System

K182470 · Life Spine · Orthopedic

Nov 2018

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K182470 is an FDA 510(k) clearance for the Plateau Spacer System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Life Spine (Huntley, US). The FDA issued a Cleared decision on November 26, 2018, 77 days after receiving the submission on September 10, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K182470 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2018
Decision Date	November 26, 2018
Days to Decision	77 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.