Cleared Special

Reliance Lumbar IBF System

K183049 · Reliance Medical Systems, LLC · Orthopedic

Feb 2019

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K183049 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 February 15, 2019, 105 days after receiving the submission on November 2, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K183049 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2018
Decision Date	February 15, 2019
Days to Decision	105 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.