Cleared Traditional

RELIANCE LUMBAR IBF SYSTEM

K113540 · Reliance Medical Systems, LLC · Orthopedic

Mar 2012

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K113540 is an FDA 510(k) clearance for the RELIANCE LUMBAR IBF SYSTEM, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on March 12, 2012, 103 days after receiving the submission on November 30, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K113540 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2011
Decision Date	March 12, 2012
Days to Decision	103 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.