Cleared Special

Reliance Cervical IBF System

K173102 · Reliance Medical Systems, LLC · Orthopedic

Dec 2017

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K173102 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 December 29, 2017, 91 days after receiving the submission on September 29, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K173102 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2017
Decision Date	December 29, 2017
Days to Decision	91 days
Submission Type	Special
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.