Cleared Traditional

RELIANCE CERVICAL IBF SYSTEM

K120396 · Reliance Medical Systems, LLC · Orthopedic

May 2012

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K120396 is an FDA 510(k) clearance for the RELIANCE CERVICAL IBF SYSTEM, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on May 8, 2012, 90 days after receiving the submission on February 8, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K120396 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2012
Decision Date	May 08, 2012
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.